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Working in an industry requires you to adhere to certain rules and regulations. With our vast experience in regulated environments such as Medical Devices, Diagnostics and Pharmaceuticals, we enable our clients to achieve their goals in a compliant and high quality manner. With the tool of external audits, we provide a possibility for any organisation to have an outside view on their processes and workflows. This can help any organisation in preparation of a re-certification audit or to identify improvement potentials actively.

Our Quality Assurance service is based on our experience profound knowledge of various ISO norms such as ISO 9001, ISO 13485 which we gained through a multitude of internal and external audits. In Medical Devices and Diagnostics we have in-depth knowledge of the current versions of the following regulations: ISO 13485, ISO 14971, FDA CFR 21 Part 11 and Part 820, the Medical Device Directive (MDD - 93/42/EEC), the Active Implantable Medical Device Directive (MDD - 90/385/EEC), In-vitro Diagnostic Devices (IVDD - 98/79/EC). 

As a solution provider, we support you by conducting workshops to identify suitable strategies for continuing success. Once the strategy is defined, rameus solutions can assist with the implementation through Process Management and Maturity Assessments expertise or if required individual coachings.

We focus on your quality to achieve sustainable success!

 

Feel free to contact us if you have an inquiry. We will gladly get back to you.