Regulatory review

Our knowledgeable team of Quality and Regulatory experts come from a diverse range of backgrounds, spanning the pharmaceutical, medical device, diagnostic and consumer product worlds.

We can review your design against the requirements of

• Medical Device Regulations (MDR)
• In-vitro diagnostic regulations (IVDR)
• Medicinal Product Directive (MPD)
• Medical Device Single Audit Programme  (MDSAP)

Operating globally, we work to Code of Federal Regulations Title 21 part 820 Quality System Regulations and to ISO 13485.
In addition, we can author regulatory pathways and develop strategies to bring your product to market in a compliant and time efficient manner.

Other relevant pages:

• Quality Management Systems >
• Design History File / Technical File creation >
• Design History File / Technical File remediation >