Medical Device Manufacturer
Supplement Factory is proud to be a an ISO13485 Medical Device Manufacturer. Our GMP factory, warehouse and quality management system (QMS) have been inspected by the notified body LRQA (CE0088) and deemed acceptable for manufacture. In addition, we are able to supply own label medical device products under license to 3rd parties.
About Medical Devices
A medical device is defined as a material used for human beings for the purpose of prevention, treatment or alleviation of disease and which does not achieve it’s principle intended action in the human body by pharmacological, immunological or metabolic means.
A medical device is thus intended for the Treatment of a disease e.g. our Fat binder is used for the treatment of Obesity and Excess Weight.
Food supplements simply supplement the diet allowing the use of authorised health claims e.g. “Vitamin C contributes to the normal function of the immune system”, but no treatment claims are not permitted.
Medical devices can only be placed on the market following approval of the product Technical File by the Notified Body (appointed by the MHRA). This ensures a full and ongoing review of the product including the manufacturing process, product stability, quality checks and the clinical evidence to support the product’s treatment claims.
Supplements can be manufactured & marketed without any third-party checks provided the label complies with supplement legislation. They also do not need to be made by an accredited medical device manufacturer.
An oral medical device such as a Fat Binder should be made in a facility with appropriate accreditations and demonstrable expertise in the manufacture and control of such products. The product should be regulated by a reputable Notified Body such as LRQA and carry a CE mark.
It is important that the ‘medical device manufacturer’ take full legal responsibility for the product and ensure contracts are in place with any distributors to ensure they are aware of their responsibilities for this regulated product. The product should have a live technical file that is constantly updated and subject to surveillance audit by the Notified Body.
What our people say
“Manufacturing medical devices that we have developed in-house is something I am very proud of. Our collaborations with the University of Greenwich to develop these licenses have been a personal pleasure for me and I am always overjoyed when we offer the medical devices under a new label in a different European territory”. Greg Burnard, General Manager & Qualified Person.
Quality, Quality, Quality
Supplement Factory is a fully accredited facility. Our quality management systems are the backbone of our growing enterprise. As a well known Kent based supplement manufacturer, that takes pride in everything that we do, it is with pleasure that we invite you to inspect some of our other accreditations:
Medical Device Manufacture is at the heart of our business. We work to the strict guideline set by the notified body working on behalf of the MHRA.
Find Out More
Whether your brand or company is looking at taking an organic, natural or holistic route to market, we have the expertise to guide your green ambitions. Our experienced relationship managers will support your brand values and aspirational ideas to help you craft a finished product that fits your ethical standards and yields a return that meets your budget demands.