QUALITY ASSURANCE SERVICES

Clarvin´s consultants have extensive knowledge and experience in all aspects related to quality management and quality assurance. We can support you in developing and implementing a quality management system (QMS) in accordance with Medical Device regulation (MDR), ISO 13485 and 21CFR820 (QSR) requirements.

If requested, we can as your company´s Quality Assurance expert and take care of all quality management system related activities (eg. management review, internal audit, CAPA, supplier audits, control of economic operators).

Example of Quality Assurance Services

• MDR Gap Analysis
• Gap Analysis (eg. ISO 13485, QSR)
• Establishing a quality system according to the requirements for medical devices, including required processes, procedures, instructions and forms
• Monitoring and adjustment of your QMS
• Conducting internal, supplier and economic operator audits
• Preparation for and assistance during external audits