Do you want to provide your customers with the best transferdevice for reconstituting their lyophilizates? Then visit us at our booth and let us convince you of our nextaro family.
nextaro - for better solutions
And if you need an experienced and qualified manufacturer of high-quality disposable medical devices for your existing or newly developed pharmaceutical product, then you are also in the right place at our stand. We will be happy to discuss possible cooperations with you.
sfm - precise understanding
]]>You can find more information about the cooperation and the topics covered here and in the download area.
Link to B.A.U.M. e.V.: Indikatoren für Nachhaltigkeitsleistung, die planetare und gesellschaftliche Belastungsgrenzen ernst nehmen (baumev.de)
]]>Our core competences cover all realization stages from development to production and registration of high-quality medical disposable products. We would also be happy to realize your product idea!
Please feel free to make an appointment in advance.
Our team is looking forward to meeting you!
]]>From September 20th, 2023 to September 21st, 2023, we will be showcasing at the event in Galway, presenting our latest innovations and technologies in the field of medical technology. Our focus will be on the nextaro® product family, for the reconstitution of lyophilized drugs. This event provides an excellent opportunity to stay informed about the latest industry developments and engage with experts.
Visit our booth, number 211 on the second floor, and discover how our products and solutions contribute to enhancing healthcare and providing innovative approaches to medical challenges. We look forward to meeting you at the Medical Technology Ireland Exhibition and collectively shaping the future of medical technology. Don't miss out on this opportunity!
#MedTechIreland #InnovationInHealthcare #medicaldevice #nextaro
]]>On the occasion of the company's anniversary, majority shareholder Dipl.-Ing. Peter Wagner reminisced over the development and success of the company. Through continuous progress and hard work, the foundation for sfm’s own product family, nextaro®, was laid. Now, with costs of around 20 million euros, the largest investment in the company's history is underway. The construction of one of the most modern sterilization facilities and the expansion of the logistics area became possible through the acquisition of the neighboring property, the former bus terminal of Kreiswerke Main-Kinzig.
Mayor Weiher attributes the success story of the company to the excellent collaboration between shareholders, management, and the 250 employees. The constellation of sfm's leadership with its advisory board is truly exceptional, as the support from advisory board members has had a positive impact on the company. The city of Wächtersbach takes great pride in the tremendous growth the company has achieved throughout its history.
Thorsten Stolz, the head of district authority, also praised sfm medical devices GmbH as a flagship company in the Main-Kinzig district, highlighting its impressive journey from a "precision engineering company" to a developer of modern medical technology. Both he and Mayor Andreas Weiher still vividly remember the negotiations with Kreiswerke Main-Kinzig. Supporting sfm's expansion was unquestionable for Stolz and Weiher, considering the company's significance as an employer with 250 employees (in addition to 120 employees in subsidiaries in Prague) for the district and the region, an importance recognized by the Chamber of Industry and Commerce (IHK). The only challenge was to find an alternative location for the bus terminal.
We would like to express our gratitude to District Administrator Thorsten Stolz and Mayor Andreas Weiher for their strong support during the negotiations with Kreiswerke Main-Kinzig.
Our longstanding success would not have been possible without the outstanding collaboration of our shareholders, management, advisory board members, and dedicated employees at all locations. We take great pride in being such a significant employer for the region and remain committed to preserving our family-owned roots in the future.
Our 70th anniversary is a reason to celebrate, rejoice, and give thanks. We extend our heartfelt thanks to everyone who has accompanied us on this successful journey.
70 years have been accomplished - and we are ready to tackle the next 70 years with dedication!
Your team at sfm medical devices GmbH.
]]>
We firmly believe that every child has the right to be loved, cared for and have the best quality of life possible, regardless of their health situation. We hope that our donation will support the necessary expansion of the facility and would like to take this opportunity to thank all the employees of sfm medical devices GmbH whose dedication and hard work helped make this donation possible. It is inspiring to see our team come together to make a positive impact in the lives of others..
We also encourage our community and business partners to support Kinderhospiz Bärenherz. Every donation, whether financial or through volunteerism, makes a difference and helps make the lives of children and their families a little brighter.
Start - Kinderhospiz Bärenherz Wiesbaden (kinderhospiz-wiesbaden.de)
Together we can create a better future. Thank you for your support!
Your team from sfm medical devices GmbH
]]>
We are pleased to announce that we have expanded our cleanroom capacity for the production of medical disposables at the Wächtersbach and Prague sites by over 750m². This brings the group's total cleanroom manufacturing space to approximately 3,000m². These cleanrooms have been specially designed to meet our requirements for manufacturing our products in ISO 8 cleanroom conditions (DIN EN ISO 14644).
Our cleanrooms are equipped with the latest technology, which is crucial for the quality of our products. Besides a permanent monitoring and regulation of the air quality we use special cleanroom garments to minimize contamination by particles or germs.
With the completion and validation of our new cleanrooms, we are now able to implement additional manufacturing and assembly technologies to produce disposable medical products under optimal conditions. We are proud of our employees who have realized this project through their commitment.
Our customers from the medical and pharmaceutical industry expect flawless products. We are pleased to have created the best possible manufacturing environment to provide our customers with products of the highest quality. The first production lines have already started in our new clean rooms to support our customers with our innovative solutions. Overall, the expansion of our cleanrooms represents an important step to further strengthen both locations and secure jobs.
Are you looking for a partner who can support you with high-quality medical products manufactured using state-of-the-art cleanroom technologies? We will be happy to advise you!
info@sfm.de or +496063/8050
]]>
Our customers can now supply their patients with lyophilized pharmaceuticals, which are reconstituted using a transfer device that meets the high-quality requirements of the EU MDR.
nextaro® - for better solutions
]]>
Are you looking for the best method to reconstitute lyophilized pharmaceuticals? Then visit us at our booth and let us convince you of our nextaro family.
nextaro - for better solutions
If instead you need an experienced and qualified manufacturer of high-quality disposable medical devices for your existing or newly developed pharmaceutical product, then you are also in the right place at our stand. We will be happy to discuss possible cooperations with you.
sfm - precise understanding
For more information on the fair visit: Pharmapack Europe | Innovation, Networking, Education
]]>We cover all implementation stages from development to production and the registration of high-quality customized medical devices.
Our team is looking forward to meeting you!
]]>01st - 03rd November | Messe Frankfurt | Booth 30A90!
You are looking for a new, high-quality medical product for your medication? Our team will be pleased to provide you in personal with advice on development and production.
sfm medical devices GmbH at CPHI Frankfurt 2022 (cphi-online.com)
]]>
Many medical device manufacturers are aware of the burden and expense of performing various audits and inspections due to regulatory requirements in different countries. This has given rise to the desire to centralize this dispersed effort through a single, yet comprehensive, audit.
The following countries and authorities are combined under MDSAP:
| Country | Authority | QM-Regulations |
|---|---|---|
| Australia | Therapeutic Goods Administration TGA | Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3) |
| Brazil | Agência Nacional de Vigilância Sanitária (ANVISA) | Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013) |
| Canada | Health Canada | Medical Device Regulations – Part 1-SOR 98/282 |
| Japan | Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) | Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169) |
| USA | Food and Drug Administration FDA | 21 CFR Part 803 21 CFR Part 806 21 CFR Part 807 – Subpart A to D 21 CFR Part 820 |
In the meantime, an audit according to MDSAP is mandatory for access to the Canadian market.
We are proud of our performance during the certification audit and are looking forward to serve new markets.
]]>18 - 19 May | Paris Expo, Porte de Versailles | Paris, Booth C48 Hall 7.2
On-site we will showcase our extended nextaro® product family, designed for the reconstitution and transfer of drugs. See what’s new.
You have a need for a new unique medical device for your medication? Join us at booth C48.
#Pharmapack2022 #nextaro #medicaldevice #transferdevice #reconstitution #pharma #teamsfm
]]>With a festive opening and subsequent celebration on 15 October, the new building of safetec medical engineering s.r.o. in Prague was formally inaugurated.
The Managing Director of the sfm Group, Mr. Peter Strötgen, thanked all those involved who had contributed to the success of the fantastic new building. The new facility is inviting, modern and open, just like the safetec team. We wish continued success on the new site.
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
We are exhibiting in Hall 13 Stand C44 and are looking forward to meeting YOU.
Schedule an appointment in advance with us, we will be happy to spend the time with you.
https://www.compamed.de/vis/v1/de/exhibitors/medcom2021.2682668?oid=53320&lang=1&_query=sfm
]]>Take the chance to visit us personally at the exhibition and discuss with our competent staff the possibilities of new new medical devices for your pharma products.
]]>
Take the chance to visit us personally at the exhibition and discuss with our competent staff the possibilities of new new medical devices for your pharma products.
Please visit this website for further informations: Open
]]>sfm medical devices, a medium-sized med-tech company based in Wächtersbach, sees itself as responsible for providing support in the currently tense procurement situation for protective masks. At the end of March, a concept was developed in collaboration with the company's Medical Advisory Board Member, Dr. Haindl, medical technology expert from Wennigsen (Hanover area, Lower Saxony), to reprocess used protective masks.
sfm medical devices operates a large sterilization chamber at their site in Wächtersbach. In this facility, medical devices are sterilized by means of ethylene oxide (ETO) and can therefore be used on patients. The EO sterilization process is also suitable for killing enveloped viruses and thus the corona virus SARS-CoV-2/ COVID-19.
The BMG (Federal Ministry of Health) has asked the BfArM (Federal Institute for Drugs and Medical Devices) to evaluate the ETO sterilisation of protective masks. The BfArM will recommend that ETO sterilisation be named as the 1st alternative for decontamination during emergency supply shortages of respiratory protective masks.
The BMG has initially limited the reprocessing measures (max. 6 months to build up own production capacities in Germany during this time).
sfm plans to organize a personalized collection of used MNS masks (surgical masks) but also FFP2 protective masks by the hospital, nursing service or doctor's practice. The masks will be double packed in so-called sterile bags by trained personnel in the facilities and then sent to sfm medical devices. There the sterilisation process takes place and within approx. 5 days the masks can be returned and reused by the staff.
sfm plans to offer this service FREE of charge until further notice and if capacity is available.
The District Administrator of the Main-Kinzig-Kreis, Mr. Thorsten Stolz, as well as the Mayor of Wächtersbach, Mr. Andreas Weiher, are involved in the initiative. Both have already contacted the Main-Kinzig clinics, nursing services and medical practices in order to actively help as district and local authorities to support the supply of protective masks in the way shown.
Interested clinics, nursing services or medical practices can request further information on the campaign from sfm medical devices via e-mail to steri@sfm.de.
Under this address, sterilizations for the reprocessing of masks will also be registered and processed.
Further information can also be found on the homepage at www.sfm.de.
]]>
sfm takes the growing concerns about the COVID 19 virus very seriously and is monitoring the outbreak and its potential impact on our business very closely. Our current focus lies on ensuring the safety of our personnel while continuing to deliver medical devices of the highest quality to our customers and their patients who rely on us.
At present, we have not yet had any significant impact on our daily business processes. The continuing supply of the necessary raw materials and supplies for our production, as well as the movement of goods between Wächtersbach and our subsidiary in Prague, is currently ensured.
We are daily monitoring the situation in all departments both in Germany and the Czech Republic. The following measures have been taken to protect our employees, customers and suppliers:
We apologize if current inquiries cannot be answered in the usual fast way. We will do our utmost to ensure your punctual delivery.
We hope for your understanding and wish you all the best, especially health, in these turbulent times.
Best Regards from Wächtersbach
Ralf Blomeyer on behalf of the whole sfm group
This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: https://www.pharmapackeurope.com/exhibitors/sfm-medical-devices-gmbh
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
We are exhibiting in Hall 8A Stand J11 and are looking forward to meeting YOU.
Schedule an appointment in advance with us, we will be happy to spend the time with you.
This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: https://www.cphi.com/
]]>The Swiss Medtech Expo is the Swiss meeting place for the medtech supplier industry with the most important exhibitors, innovations, application examples, exhibits, expert lectures and much more. We at sfm swiss medical AG look forward to welcoming you to our stand and getting to know you. You will find us in Hall 2 Stand C 2075.
Don't miss our presentation on the development of the new nextaro transfer system. The new quality benchmark in the reconstitution of lyophilized drugs.
#medical #pharma #nextaro #medicaldevices #drugdelivery #smte19
This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: https://medteclive.com/en/ausstellerprodukte/mtl19/exhibitor-41101605/sfm-medical-devices-gmbh
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: https://www.pharmapackeurope.com/exhibitors/sfm-medical-devices-gmbh
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
We are exhibiting in Hall 8A Stand J11 and are looking forward to meeting YOU.
Schedule an appointment in advance with us, we will be happy to spend the time with you.
https://www.compamed.de/vis/v1/de/exhibitors/medcom2018.2580887?oid=53322&lang=1
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: https://www.cphi.com/europe/exhibitors/sfm-medical-devices-gmbh
]]>nextaro® was created based on market-demands. Focussing on user safety as the starting point of this new development resulted in maximum stability, excellent haptics, and safe as well as intuitive handling of nextaro®. Our customers benefit from being able to combine their high-grade medicinal product with an appropriate high-quality medical device, offering their patients the best possible care. Nextaro®‘s modular design allows the system to be adapted to the different requirements of various lyophilized drugs.
We were honoured with the "Patient centricity and customisation" award for nextaro®, giving us the confirmation that it is the perfect product for the reconstitution of lyophilized drugs.
https://www.pharmapackeurope.com/2018-pharmapack-awards-winners
nextaro® - Turning market demands into solutions
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: https://www.pharmapackeurope.com/
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
We are exhibiting in Hall 8A Stand J11 and are looking forward to meeting YOU.
Schedule an appointment in advance with us, we will be happy to spend the time with you.
https://www.compamed-tradefair.com/vis/v1/en/exhibitors/medcom2017.2543569?oid=53322&lang=2
]]>These will now consistently be implemented. This continuous process of improvement is the foundation of our strong market position, and makes us the leading partner for the development and production of single use devices for the medical and pharmaceutical industry.“
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: http://www.medteceurope.com
]]>Visit us at booth D44 or contact us directly:
Phone: +49 (0)6053 805-0 | info@sfm.de
This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations: http://www.pharmapackeurope.com/exhibitors/sfm-medical-devices-gmbh
]]>This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
We are exhibiting in Hall 08a Stand J11 and are looking forward to meeting YOU.
Schedule an appointment in advance with us, we will be happy to spend the time with you.
]]>
MD&M Minneapolis is a perfect opportunity to find out how sfm can accelerate your time to market and improve your supply chain’s performance.
Please visit this website for further information: http://mdmminn.mddionline.com/
This trade fair is the ideal environment for us to present ourselves to our customers and interested parties as an OEM supplier.
Please visit this website for further informations:
http://analytica-media.de/prj_277/view/index.cfm?nv=1.1.1&LNG=1&elb=277.1100.2944.1.1111
What is so special about sfm?
As in every successful company, the employees are in the foreground with us. With a great sense of responsibility and effort, they ensure the quality of our products every day. Many of their colleagues, who have already completed their vocational training with us, remain with sfm until their well-earned retirement. In our present society oriented towards short-term success, this is no longer a common occurrence.
sfm medical devices GmbH does not have any specifically formulated "Vision", as it is known in other companies. Our corporate strategy is precisely and transparently formulated: We see ourselves as partner to the medical technology and pharmaceutical industry, we consistently focus on the OEM business, and we aspire to contribute towards our customers and partners becoming more successful in international markets. If together we succeed in improving the healthcare and well-being of the patients, we feel justified in what we do.
We do not rest on our successes but rather continually work to expand on them through sustainable investments in process development, in machines and buildings, and in the further training of our employees. We are supported in these efforts by our stakeholders, who have the long-term survival of the company in mind.
Due to the continuous increase in life expectancy and the associated increase in age-related diseases, the healthcare industry is a growth market. The challenges associated with the opportunities and risks have created a global competition in which only the best can survive. As with every market segment, medical technology is also subject to economic cycles, economic crises and specific market changes. As a small individual company, one is not able to stop these waves - one can, however, learn to "surf" them! Here we are benefited by the experience from the last 60 years and the direct and personal dialogue with our customers.
There is probably no secret recipe for economic success. We at sfm intend to continue with what made us strong: being a flexible, competent partner in the resolution of the individual tasks assigned by our customers. This automatically means the further development of our production processes and the creation of new products and services for medical technology and the pharmaceutical industry. Especially for medium-size companies such as sfm, the global competition, the associated continuously increasing cost pressures and the regulatory requirements, which are developing at a rapid pace, represent a special challenge.
I extend my thanks to all of you who have taken the time to read these lines, and I hope to be able to welcome you personally at the next opportunity.
Sincerly yours,
Dr. Alexander Dziengel
What is so special about sfm?
As in every successful company, the employees are in the foreground with us. With a great sense of responsibility and effort, they ensure the quality of our products every day. Many of their colleagues, who have already completed their vocational training with us, remain with sfm until their well-earned retirement. In our present society oriented towards short-term success, this is no longer a common occurrence.
sfm medical devices GmbH does not have any specifically formulated "Vision", as it is known in other companies. Our corporate strategy is precisely and transparently formulated: We see ourselves as partner to the medical technology and pharmaceutical industry, we consistently focus on the OEM business, and we aspire to contribute towards our customers and partners becoming more successful in international markets. If together we succeed in improving the healthcare and well-being of the patients, we feel justified in what we do.
We do not rest on our successes but rather continually work to expand on them through sustainable investments in process development, in machines and buildings, and in the further training of our employees. We are supported in these efforts by our stakeholders, who have the long-term survival of the company in mind.
Due to the continuous increase in life expectancy and the associated increase in age-related diseases, the healthcare industry is a growth market. The challenges associated with the opportunities and risks have created a global competition in which only the best can survive. As with every market segment, medical technology is also subject to economic cycles, economic crises and specific market changes. As a small individual company, one is not able to stop these waves - one can, however, learn to "surf" them! Here we are benefited by the experience from the last 60 years and the direct and personal dialogue with our customers.
There is probably no secret recipe for economic success. We at sfm intend to continue with what made us strong: being a flexible, competent partner in the resolution of the individual tasks assigned by our customers. This automatically means the further development of our production processes and the creation of new products and services for medical technology and the pharmaceutical industry. Especially for medium-size companies such as sfm, the global competition, the associated continuously increasing cost pressures and the regulatory requirements, which are developing at a rapid pace, represent a special challenge.
I extend my thanks to all of you who have taken the time to read these lines, and I hope to be able to welcome you personally at the next opportunity.
Sincerly yours,
Dr. Alexander Dziengel
Our regulatory affairs specialists prepare technical documentation in collaboration with product development, quality management, marketing and the customer. This provides a full description of your products. From the first idea up to CE certification or registration, only with proper, conforming documentation may the product be legally sold.
In addition to product-specific descriptions, the technical documentation contains among other things a comprehensive risk assessment and details regarding the suitability for use.
The clinical evaluation is also part of the documentation. It is prepared in accordance with MEDDEV or GHTF specifications. sfm has an extensive network of qualified experts with product-related and medical know-how at its disposal to prepare these clinical assessments.
As a provider of integrated medical technology solutions, sfm offers its customers a complete package of services — even in the realm of Regulatory Affairs. From the very beginning, we help you along the path to the successful marketing of your products.
]]>Our regulatory affairs specialists prepare technical documentation in collaboration with product development, quality management, marketing and the customer. This provides a full description of your products. From the first idea up to CE certification or registration, only with proper, conforming documentation may the product be legally sold.
In addition to product-specific descriptions, the technical documentation contains among other things a comprehensive risk assessment and details regarding the suitability for use.
The clinical evaluation is also part of the documentation. It is prepared in accordance with MEDDEV or GHTF specifications. sfm has an extensive network of qualified experts with product-related and medical know-how at its disposal to prepare these clinical assessments.
As a provider of integrated medical technology solutions, sfm offers its customers a complete package of services — even in the realm of Regulatory Affairs. From the very beginning, we help you along the path to the successful marketing of your products.
]]>