Ensure ISO 13485 Medical Devices Compliance, Improve Efficiency and Increase Profits

Retaining the services of an ISO 13485 Medical Devices consultant will help your company meet the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

Since implementation of the ISO 13485 standards in 2003, compliance with these standards has come to be seen as a fundamental first step in ensuring the medical devices you manufacture or developing are in compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted in the European Union.

David Owens & Associates are proficient in ensuring that your company will be able to meet ISO 13485 Medical Devices compliance requirements, and in assisting you develop ISO 9000 business management systems. Our goal is to assist you in raising standards, improving efficiency and increasing profits.