- ISO 13485:2012 Medical Device - Quality Management Systems
ISO 13485:2012 is the international standard that is the normal route for manufacturers and distributors of medical devices to demonstrate compliance to the quality system and regulatory requirements in Europe, Canada, Japan, Australia and many other countries.
ISO:13485:20012 provides a harmonized model for quality management system requirements in the international market.ISO13485:2012 is similar to ISO9001:2008 with additional mandatory requirements for medical devices Our consultants begin the certification process by conducting a Gap Analysis of your systems and documentation. The analysis report identifies the areas that are not in compliance with the ISO13485:2012 requirements and includes an action plan and timescale for full system implementation
European CE Marking ComplianceLawrence-Hall Consultants Working closely with you, develop and implement your quality system and technical files. Our highly experienced and qualified consultants take the burden and stress from you and ensure your systems and documentation will meet the regulatory requirements. Should you wish, your consultant will be present during the Notified Body assessment.
A manufacturer or distributor of a medical device intending to place a Class 1, 2a, 2b, or Class 3 medical device on the market within Europe under their own name must demonstrate compliance to the requirements of the EU Council Directive 93/42/EEC as amended by 2007/47/EC. Conformity to the directive is evidenced by the CE Mark.
There are several routes to achieving compliance to Directive 93/42/EEC and CE Marking. The normal route is by the application of an ISO13485:2012 quality management system together with a Technical File (Dossier) that complies with the relevant annex of Directive 93/42/EEC as amended by 2007/47/EC. In the case of Class 2 and 3 devices the quality system and technical files are assessed by an independent third party Notified Body
Our consultants begin the certification process by conducting a Gap Analysis of your systems and documentation. The analysis report identifies the areas that are not in compliance with the Directive 93/42/EEC requirements and includes an action plan and timescale for full system implementation