Quality assurance

Do you need assistance in obtaining your ISO 13485 certification ? Do you need to implement a quality management system compliant with 21 CFR part 820 ?

We can help you manage your Quality Assurance in the following ways :

• Set up and maintain your ISO 13485 or 21 CFR 820 quality management system,
• Create your Quality Manual, processes, procedures, and forms,
• Adapt your quality management system to medical CE marking,
• Add the necessary instructions to comply with MDR and FDA regulatory requirements, complementary to ISO 13485,
• Train your staff,
• Conduct internal audits of your processes,
• Validate or revalidate your processes,
• Validate or re-validate your equipment and software,
• Act as your company’s outsourced quality manager,
• Support you during ISO 13485 stage 1 and stage 2 certification audits.

Most companies achieve ISO 13485 certification on the first attempt. In most cases, the company must resolve non-conformities identified by the certification body. Major non-conformities are resolved between Stage 1 and Stage 2 audits.

An often underestimated task is to maintain the system in place, while the company mobilizes its resources on product R&Q or the commercial effort to win its first contracts. Nothing is more frustrating than having to intervene in “fire brigade” mode when the deviations identified by the certification body have not been resolved on the eve of a follow-up audit.

We can help you in all these phases of your company’s life, when quality assurance constraints must not be sidelined.