Global healthcare systems require medical devices that are safe and effective in the diagnosis, treatment and prevention of diseases, and physicians rely on a wide range of medical devices to help identify and treat said ailments.
However, for medical devices to be considered both safe to use and effective for their intended purpose, they must be approved by a regulatory body such as the FDA. These approval processes are complex, and manufacturers often seek expert advice from medical device consultants to help get their products onto the market.
Continue reading to learn how medical device consulting supports regulatory applications for a global market.
What is Medical Device Consulting?
Developing a new medical device for the market can be a lengthy and challenging process. Many requirements must be met from the initial concept through the final stages of approval and into post-market use.
Medical device consulting is an option for organizations that require additional support during the device development process, implementation of new regulations or when making changes to existing devices. DS InPharmatics consulting services include device classification, identifying a suitable predicate, identification of applicable standards, completing guidance documents and regulations, identifying required testing and documentation required for a successful submission, as well as support writing submissions and compiling registrations and input for clinical studies.
Why is Medical Device Consulting in Demand?
Medical device consulting is a highly sought-out service by large companies that require additional assistance for special projects, smaller start-ups that don't have a substantial quality regulatory department and individual physicians who have developed new or modified devices to improve what is already available on the market.
DSI's consultants work with worldwide regulatory agencies on a consistent basis to understand their specific requirements. Our experts provide invaluable advice and strategies to companies working to launch a medical device onto the market, and can prepare the needed submissions or registrations. Throughout this complex process, consultants can offer expert advice on developing or revising a Quality Management System (QMS), identify gaps, and provide the latest knowledge on the most recent versions of regulations, guidance documents and standards that are applicable to a specific device submission.
Worldwide regulatory requirements are unique to each country and are constantly changing. Therefore, it can be difficult to maintain current knowledge of every regulation or directive set by individual regulatory bodies. Hiring consultants with expertise can be beneficial in order to save a manufacturer time and money. Major markets for medical devices include the U.S. FDA and EMEA, through Notified Bodies and Competent Authorities. Worldwide registrations can be performed once a medical device is approved for market in one or more of these markets.
Medical Device Consulting with DS InPharmatics
DSI offers a range of consulting services to support companies involved in the development of new medical devices and registration of devices to new regulations and strategies for making changes to existing devices.
The DS InPharmatics team offers extensive experience with global regulations, which allows our consultants to devise comprehensive strategies that lead to medical device market approvals worldwide. An outline of our medical device services includes:
- Medical Device Development Strategies
- Risk Analysis (FMEA and Hazard Analysis)
- Medical Device Regulatory Strategies
- Worldwide Regulatory Applications
- 510(K) Medical Device Application
- Investigational Device Exemption (IDE) and Medical Device Clinical Studies
- Premarket Approval Application (PMA)
- Post-Market Approval Requirements and Activities
Contact DSI’s consultants for more information to learn how our services can support getting your device approved to market as quickly and seamlessly as possible.
