Regulatory clearance of new medical devices is one of our strengths. Pega Medical Services’ strong technical background, coupled with a solid understanding of US-FDA and Canadian regulatory requirements, has been a key factor in submitting successful pre-market applications. Pega Medical is ISO 13485:2003 and ISO 9001:2008 certified.
Our regulatory services include:
US-FDA 510K submissions
Health Canada Medical Device License (MDL) Applications
Europe CE Marking
Expertise in South American regulatory issues
Let us help you navigate the regulatory process and bring your products to market.