Quality Assurance

Companies in the medical device sector must adhere to strict quality standards and regulations, such as the requirements of ISO 13485 or MDSAP. A deficiency in a requirement can impact process compliance.

It is therefore necessary to install, implement, and maintain a quality management system correctly.

• Implementation of quality management systems according to the ISO 13485 standard: Targeted consulting for the review and/or preparation of documentation required by the ISO 13485 standard. In collaboration with company representatives, we will adjust procedures to the company's reality while remaining compliant with required standards, avoiding the creation of excessive documentation layers that do not fit a flexible system well.

• Quality Assurance Manager for micro and small businesses: We offer the service of a Quality Assurance Manager for companies that prefer to outsource the activity for cost efficiency and result maximization.

• Supplier qualification: Dedicated consultation for the objective identification of critical suppliers, their qualification, and the development of a supplier monitoring plan consistent with the level of criticality and risk for the company.

• Assistance in planning, design, and development: Targeted consultation to improve the design process by providing organizational support in operational management that helps the company keep control over the executive, economic, and documentary aspects of the design itself.

• Support in identifying processes and process-related risks: We provide dedicated consultation for companies that are approaching process identification for the first time or need to revise process identification based on risk analysis. We assist the company in critically evaluating its own processes and those of third parties it manages, ultimately determining their impact on the product or the company itself.

• Support in selecting the Certification Body: We assist companies in selecting the Certification Body to collaboratively establish the best approach for constructive dialogue and lead the company to succeed in certification and interaction with the Certification Body.

Why FTR ADVISOR? Because we believe that standards are valuable materials that need to be tailored to the company context to become unique tailored suits.