NAVIGATING THE GREY OF MEDICAL DEVICE REGULATION℠
Navigating the Regulatory Process for Medical Device Approval
Clients in the medical device industry come to us for a multitude of reasons. From bringing new life-saving devices to market, to updating compliance for products that have been improving the quality of patients’ lives for years. Our passion lies in partnering with clients while helping them to navigate the complex world of regulatory approval. That means aiding in everything from first-in-human clinical testing to market-launch regulatory strategy. As technological advancements continue to improve the quality of life, being able to understand and interpret the complexities of the regulatory process has also become vital to achieving approvals. Creating a playbook that will serve as your guide for bringing a medical device to market from concept to implementation is just one of the many ways we help clients achieve those approvals.
Regulations in the medical device industry are intended for the critical purpose of maximizing the effectiveness medical devices, while improving and protecting the lives of the patients they serve. Navigating those regional laws, however, can be an equally critical task. JW Regulatory Consulting was founded with both those ideas at heart. We’re enabling businesses in the medical device world to understand regulations while leveraging them in order to bring new devices to market or, as regulations change, help legacy products to remain in compliance. Improving the quality of life while helping people is a passion we share in common with the businesses we work with. And, translating highly technical information into sound regulatory dossiers that tell truthful and accurate stories for our clients is at the forefront of how we do it.
Go-To-Market Regulatory Strategy
Regulatory Agency Pre-Sub Meetings
Gap Analysis and Remediation Plans
Quality Systems Audits & FDA Mock Inspections
Regulatory Due Diligence
Clinical Evaluation Reports
Responding to FDA 483 Observations & Warning Letters
Advise on Design Verification & Validation Data Requirements
Pre-Market and Post-Market Risk Management
Labeling & Promotional Material Review
What Do Our Clients Look Like?
From understanding the medical space you’re operating in to the highly specific applications of your end users, we’ve helped clients with everything from interpreting medical regulations to design verification and validation test plans to agency meetings and go-to-market strategies. With backgrounds in both business and science, our team at JW Regulatory Consulting partners with companies of all sizes and specialties ranging from cardiovascular to neurological, coronary and urological. Have device meant for the orthopedic industry? We can help with that too. Our clients span a multitude of disciplines and regions. And, if you still have questions about how we can help, we encourage you to reach out.
If you’re thinking of bringing a medical device to the market, or need post-market regulatory compliance support, we’re here to help you navigate the grey, while helping you improve the quality of life for patients across the world.