Veracord provides quality system design, regulatory, compliance, clinical and operations consulting services for medical devices that are focused on helping managers and companies meet the aggressive challenges of bringing new medical device products to market.
Veracord’s leverages extensive medical device industry experience to assist companies move quickly through the regulatory process, reducing the false starts and mistakes that frequently result from inexperience. Veracord staff understands the challenges faced by startups as well as more mature operations. Both types of companies are faced with ground-breaking products that challenge the market as well as their processes, limited financial resources and short timelines. Veracord reduces the uncertainty (and cost) for these companies.
With many years of US and International medical device experience, Veracord has played key roles in bringing a number of diverse medical devices from concept to market. This experience includes product development, design control, clinical trials, regulatory affair strategies, the full range of Quality Systems Regulation (QSR) and compliance activities, and the creation of operations and manufacturing for a number of startup companies. Products for which approvals have been received include heart valves, pacemakers, neurostimulators, infusion pumps and IV administration products, implantable hearing systems and a number of other related products.
How We Can Help
Veracord works with you to meet the challenges of new product approvals, identifying and correcting regulatory deficiencies, improving operational systems and filling the gap when resources are limited and schedules are unrelenting. A few areas of expertise include:
- IDE (Investigational Device Exemption) and HDE (Humanitarian Device Exemption) Submissions
- PMA (PreMarket Approval) Applications and 510K Notifications
- Clinical Trial Development and Management
- Quality System Development and Implementation
- Manufacturing Process Development and Management
- Quality System Reviews, GAP analysis, Audits
- Engineering Support for Pre-Clinical Testing
- Interfacing with International regulatory bodies in Europe, Canada and the Pacific Rim.
- Warning letter and Form 483 analysis and response
Our goal is to provide a cost effective solution from concept to market for companies with limited resources. Veracord is available to help either in a small or large way, and will not add to your long term overhead expense.