Accelerate Your Medical Device Clearance: Expert Guidance for FDA 510(k), PMA Submissions, and EUMDR Compliance
Navigating the complex landscape of medical device approvals can be a daunting challenge for even the most innovative companies. At Cambridge Polymer Group, we specialize in streamlining FDA 510(k) and PMA submission processes, as well as EUMDR compliance, ensuring your device reaches global markets efficiently and compliantly.
Why Choose Cambridge Polymer Group?
- Comprehensive Expertise: Our team combines deep technical knowledge with regulatory acumen, bridging the gap between device development and successful regulatory clearance.
- Proven Track Record: With over 25 years of experience, we’ve guided numerous clients through successful FDA 510(k) and PMA submissions, addressing critical challenges in materials science, sterilization validation, and biocompatibility testing.
- Standards Leadership: As active members of ASTM and AAMI committees, we stay at the forefront of evolving medical device standards, giving your submission a competitive edge.
Our Regulatory Services
1. FDA 510(k) and PMA Submission Support
We craft tailored strategies for your FDA submissions, identifying the most efficient path to market clearance based on your device’s unique characteristics.
2. EUMDR Compliance and Remediation
Our experts provide comprehensive support for European Union Medical Device Regulation (EUMDR) compliance, ensuring your devices meet the stringent new requirements for the EU market.
3. Gap Analysis and Remediation
We conduct thorough assessments to identify and address potential regulatory hurdles before they impact your submission timeline, for both FDA and EUMDR requirements.
4. Materials Testing and Validation
Leveraging our ISO 9001:2015 certified laboratory, we provide comprehensive materials testing services crucial for regulatory submissions:
- Biocompatibility assessments
- Sterilization validation
- Chemical characterization
- Mechanical testing
5. Documentation and Submission Support
We assist in preparing robust technical documentation and reports that meet FDA and EUMDR requirements, enhancing the likelihood of first-pass success for your submissions.
Why Act Now?
The global medical device market is more competitive than ever. Delays in regulatory clearance can cost millions in lost revenue and market share. Partner with Cambridge Polymer Group to:
- Reduce submission preparation time
- Minimize the risk of regulatory requests for additional information
- Accelerate your time-to-market in both US and EU markets
Our Unique Approach
At Cambridge Polymer Group, we understand that successful regulatory submissions go beyond technical expertise. Our approach includes:
Early Team Expansion:
We advocate for bringing in peripheral skills and expertise early in the development process, ensuring all aspects of your device’s lifecycle are considered from the start.
Material Expertise:
Our deep understanding of material behavior in vivo and the regulatory bodies’ specific views on certain materials provides invaluable insights for your submission strategy.
Regulatory Gap Assessments:
We specialize in identifying and addressing gaps in your regulatory strategy, particularly for EUMDR remediation and FDA submissions.
Quality Assurance:
All our testing is conducted under our ISO 9001:2015 quality management system, ensuring the highest standards of reliability and consistency.
Contact us today for a free consultation on your FDA 510(k), PMA submission, or EUMDR compliance strategy.