MEDIcept is a vertically integrated medical device quality assurance, regulatory consulting and contract testing firm owned and managed by medical industry professionals with direct experience managing medical device development, operations, quality, and regulatory activities.
With decades of combined experience in medical device design and manufacturing and regulatory compliance, we are uniquely qualified to help medical device, in-vitro diagnostic, and plasma pharmaceutical companies navigate complex FDA and international regulatory pathways, reduce business risk and time-to-market while maximizing the potential for success in the market.
We provide our clients with a wide range of services, including:
- Regulatory strategies
- Regulatory submission
- Quality assurance system development
- Temporary Quality and Regulatory personnel
- FDA and ISO 13485 compliance audits
- Mock FDA Inspections
- Mock FDA audits
- ISO 14971 risk management system development
- Third party internal and supplier audits
- Design and regulatory due diligence
- Product corrective and preventive action program development
200 Homer Ave
Ashland, MA 01721