Optimize your medical device compliance with Valicare’s specialized consulting services

Navigating the complexities of regulatory compliance in the medical device industry requires precision, expertise, and a deep understanding of both regional and international standards.

Valicare is your partner in ensuring full compliance with the EU MDR, FDA, and other major global regulatory requirements. We offer tailored support for manufacturers aiming to meet the stringent demands of the medical device market.

Our core compliance services:

• MDR compliance
  We guide you through the complicated landscape of the EU Medical Device Regulation (MDR), ensuring your products adhere to strict European standards. Our expertise encompasses all MDR requirements, from technical documentation to Post-Market Surveillance (PMS), guaranteeing you a streamlined path to EU market approval.
• FDA compliance
  Entering the U.S. market requires alignment with FDA regulations. Valicare supports you in establishing compliant Quality Systems per FDA’s 21 CFR Part 820 and assists in FDA premarket notifications (510(k)), Premarket Approval (PMA), and other regulatory submissions for efficient access to the U.S. medical device market.
• Compliance with international regulations
  In addition to MDR and FDA, we assist in meeting regulatory requirements for other major markets, including Japan, Canada, and Australia, helping to streamline your global market entry.

Contact us today to learn how Valicare can support your journey toward compliance, innovation, and excellence in the medical device sector.