Quality

For pharmaceutical products, Dr. Nason has considerable experience liaising with Quality Assurance to align the Quality and Regulatory needs within a company.

Liaison with quality

• Regulatory assessment of proposed change controls
• Review of procedures
• Communication resulting in alignment of QA/RA needs

In addition to the above services, which are also applicable to Medical devices, Dr. Nason has direct experience in the establishment and implementation of ISO 13485-compliant quality systems.

Medical device ISO 13485 quality systems

• Creation of a start-up company’s quality system
• Work with medical device companies to effectively implement their quality system