Experienced Regulatory and Quality team
SFM manufactures all its products from its new state of the art facilities in Coventry, UK. With class 8 cleanrooms and in-house quality control and R&D laboratories.
Class 8 cleanrooms
Several class 8 cleanrooms from which all our spinning, blending, carding and needling takes place.
In house laboratories
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.
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.
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.
FREQUENTLY ASKED QUESTIONS
If you need some help, we have a list of frequently asked questions and answers. Click here to contact us.
SFM has a team of scientists with experience in manufacturing gelling fibres and x-ray detectable filaments. Our customers often come to us with bespoke concepts and we are fully equipped to help them develop their concept, using our scale-up facilities and internal research and testing laboratories. Many of our customers are in the advanced wound care and surgical sector. However we also support customers in other sectors such as food technologies, filtration technologies and the cosmetic industry.
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.
We keep some stock for the most commonly requested sizes for our x-ray detectable yarns, and therefore can deliver these on-demand. Most of our products are made to order, and whilst we often will work 12 weeks ahead with most of our customers to help manage a smooth continuity of supply which is particularly relevant with the current Covid-19 pandemic; We can often deliver in a few weeks and will try our best to meet your schedule. Packed and sterile products however will be between 8 to 12 weeks once the packaging has been fully approved.
All our products are manufactured in the UK, from class 8 clean room facilities located in Coventry. Our alginates, reinforced alginates, gelling fibre products are all manufactured from raw materials that are sustainable and using a manufacturing process which minimises waste as far as possible.
We can currently provide our products in several sizes from 5cm x 5cm cut pieces to 20cm x 30cm, although we can provide larger sizes on demand. We can provide our alginate and modified cellulose fabric in roll format, slit reels, cut pieces, ropes depending on requirements. These can be provided non-sterile or packed and sterile. Our x-ray detectable filaments can be provided in different coloring, although black and blue are most common, and in various decitex.