Medical Device Solutions
Comprehensive regulatory and compliance solutions for medical device manufacturers
Comprehensive Service Offerings
We provide specialized solutions tailored to your specific needs and challenges
Expert preparation and management of 510(k) premarket notifications
Guidance through the CE marking process for European market access
Development and implementation of ISO 13485 compliant QMS
Design and management of clinical evaluations and investigations
Comprehensive PMS systems to monitor device safety and performance
Strategic planning for efficient regulatory pathways and market access
Our Medical Device Regulatory Process
A systematic approach to navigate complex medical device regulations worldwide
Device Assessment
Comprehensive evaluation of your device and applicable regulations
Regulatory Strategy
Development of tailored regulatory pathways for your specific device
Documentation
Preparation of technical documentation and regulatory submissions
Submission & Review
Management of regulatory submissions and agency interactions
Post-Market Support
Ongoing compliance and post-market surveillance assistance
What Our Clients Say
Burwood Biotech's expertise in navigating the complex medical device regulatory landscape was invaluable. They guided us through the entire process from development to market approval with remarkable efficiency.
Jennifer Williams
VP of Regulatory Affairs, MedTech Innovations
Accelerate Your Medical Device Approval
Contact our medical device experts to discuss your regulatory needs and challenges.
Ready to Get Started?
Our team of experts is ready to help you navigate the complex regulatory landscape.
- Expert consultation
- Tailored solutions
- Ongoing support