Regulatory / International registrations
Our Regulatory team is experienced in supporting customers with their regulatory requirements. Whether for existing product changes or new product developments. In addition, SFM has several CE certified and FDA cleared products.
Our regulatory team has expertise in supporting regulatory registrations and renewals, globally, successfully. We are able to provide support for:
- Regulatory Strategy
- CE marked and FDA cleared products
- Technical file for MDR CE marking including design dossiers
- 510k preparation and application expertise/support
- Canada medical device license approval and registration
- Brazil ANVISA registrations and renewals
- Japan product registrations
- Drug master files
- Technical and regulatory information
- Other International device approvals, licensing, and registration
Certificates
Our Certificates, Standards and Regulations include:
- ISO 13485 – View our certificate, Click Here ISO 13485 Certificate
- 21 CFR 820
- Medical Devices Directive 93/42/EEC – View our certificate, Click Here CE 620062
- Medical Devices Regulation (Regulation [EU] 2017/745)
- Japan Quality Management System Compliance (MHLW Ordinance No. 169)
- Canadian Medical Devices Regulations (SOR/98-282)Quality Control
As part of its quality operations, SFM has in house analytical laboratories with a controlled environment which test products to the requirements of BS EN 13726-1. All our products are tested in house, from raw materials to finished products, by our Quality Control team prior to their use or release for onward delivery.
Our Quality team manages and operates SFM’s Quality Management System and ensures that our products are manufactured in line with our quality standards. The entire business has been structured to engage with continual improvement principles.
The Quality team is supported by a team of in-house process engineers. Our engineers contribute to the overall ethos of continual improvement and support our Quality and R&D teams with product improvements and the development of new products.
The Quality team delivers an effective quality system which supports the manufacturing of products.
- Product master files
- Managing our integrated QMS
- Supporting competent authority and notified body audits
- Maintaining compliance to our established internal requirements.
Compliance
SFM works closely with its competent authorities and regulators, and its notified body to ensure that all products and processes are fully compliant. SFM’s newly acquired multi million pounds manufacturing site in Coventry is ISO 13485, 21 CFR 820 and CMDCAS compliant.
Everything that we do at SFM is built around our customers’ requirements, and very much defined by quality. We often get asked for ways in which to navigate the current regulations and ensure that products can be launched as quickly as possible. This is where our R&D and Regulatory teams collaborate extensively in making ‘things happen’ even sometimes what others would call the ‘impossible’. At SFM we call this ‘ I’ m possible’
SFM has a huge legacy in gelling fibres manufacturing, and this experience and know-how really contribute towards the overall quality of our products. In addition, SFM is proud to manufacture in the UK, its entire product portfolio, as not only are we a mature business when it comes to our regulatory and quality experience, but we also operate and manufacture in a country which really values safety, quality and regulatory compliance.
Excellence
Our belief is that the best products and the best companies are those that match specifications and exceed expectations. This is why we focus on quality and compliance to ensure that we are able to keep on delighting our customers and enhancing the recovery of the patients we serve. Safety, Quality and Efficiency are integral in everything we do. We look to continuously comply and improve Safety and Quality whilst striving for greater efficiency in all processes.
Own Quality Control Laboratories
Long Established Know How
Silver Nanotechnology
Silver Calcium Alginate
FREQUENTLY ASKED QUESTIONS
If you need some help, we have a list of frequently asked questions and answers. Click here to contact us.
SFM’s experienced, talented and innovative regulatory team provides regulatory submissions and registrations expertise for all regulatory markets. We can also support your company with an optimized route to market for your products.
SFM implements and complies with the ISO 13485 (EU, Canada, RoW), 21 CFR 820 (USA) and Ordinance 169 (Japan). We are experts in the overall planning and delivery of regulatory compliance throughout a product’s life cycle. We deliver products CE marked and or FDA cleared. Our Regulatory Affairs and Quality team manage our Integrated QMS.
SFM complies with EU MDR; its QMS is already upgraded to comply with the MDR.
SFM also has its first products in for CE marking under the MDR and has a clear pathway for transitioning the rest of its portfolio before the end of the transition period on the 26ht of May 2024.
SFM can support you and your business in implementing MDR in your business.
1 – Where SFM is the legal manufacturer, all its products are CE marked, 510k cleared, or in most cases both.
2 – Where SFM is the OEM supplier, SFM can provide a path to CE marking, 510k clearance, or listing support for your products.
SFM manufactures devices that fall into class 2b, and class 3 in the EU, UK, and requires listing and 510k clearance notification in the USA. For your target markets, please contact us to discuss your needs.
