Medical Devices

Medical device manufacturing is a complex and wide ranging activity, covering everything from contact lenses to catheters to pacemakers.

The industry is tightly regulated and works to ISO 13845 which is generally harmonized with ISO 9001, and ISO 17025.

More recently medical devices have also been used as a means for drug delivery and as such are looking for laboratories with an understanding of both ISO17025 as well as GMP.

Butterworth have a Quality System that combines these standards and staff are familiar with the unique requirements of each standard.

All sections of the laboratory regularly undertake:

• Pharmacopoeial based work (USP, BP, EP or JP)
• Licensed and clients' own methods
• Documented in-house validated methods

In addition, the company can develop and validate methods for use on raw materials, API's or finished products. The laboratories have also undertaken work in support of process and cleaning validations.

Whether it is routine QC testing, non-routine analysis, R&D projects or advice and consultancy, clients can trust Butterworth to provide the appropriate outsourcing solution. All of our staff are committed to the aim of meeting the need for a responsive, accurate, and reliable analytical support service required by these industries.

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