Biocoat Inc

Description

The requirement does not relate to manufacturers that place only Class I (non-sterile, non-measuring devices) on the market in Europe. It is also not a requirement for manufactures that hold only ISO 13485 certification (unless they are a class I device manufacturer or a critical subcontractor or crucial supplier to a legal manufacturer). MHRA have indicated that self-test IVD devices under Annex III.6 will not receive unannounced visits as they currently do not receive a site audit; however, self-tests using Annex IV Full Quality Assurance will require an unannounced visit.

By working with Biocoat, a client gains a partner in coating commercialization. Specialized and focused experience in the area of medical device coatings is brought to bear. This knowledge can be used to supplement the research of a client's own scientific staff, or it can act as the main development house for the coating component. With 20 years of experience in creating medical device coatings, Biocoat is a trusted agent for medical device coatings commercialization.

If the Notified Body is denied access, this could place the manufacturer in breach of the contract which exists between the manufacturer and notified body. Which has potential consequences for the manufacturers CE certification. It is important to remember the criteria outlined in the Commission Recommendation Annex III, Paragraph 2 (see above). This will be taken into careful consideration during our planning process to determine where the audit will be undertaken. It is therefore important to ensure the company data is up to date and accurate.

A quality focused supplier of assorted guide wires supplied for over 15 years with the same reagents on time and to specification.

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