Global healthcare systems require medical devices that are safe and effective in diagnosing, treating, and preventing diseases, and physicians rely on a wide range of medical devices to help identify and treat said ailments.
For medical devices to be deemed both safe to use and effective for their intended purpose, approval by a regulatory body such as the FDA is required. These complex approval processes often result in manufacturers seeking expert advice from medical device consultants to support the launch of their products onto the market.
Image Credit: DSI, a PLG Company
What is medical device consulting?
The development of a new medical device for the market can be a long and difficult process. Numerous requirements must be satisfied from the initial concept to the final stages of approval and into post-market use.
Medical device consultants provide an option for organizations that need additional support during the process of device development, the implementation of new regulations, or when carrying out changes to existing devices.
DS InPharmatics consulting services include device classification, identification of a suitable predicate, identification of applicable standards, completing guidance documents and regulations, and identification of required testing and documentation for successful submission.
In addition, DS InPharmatics supports the writing of submissions, as well as compiling registrations and input for clinical studies.
Why is medical device consulting in demand?
Medical device consulting is a greatly desired service by small start-ups that do not have a substantial quality regulatory department, large companies needing extra assistance for special projects, and individual physicians who have created new or modified devices to improve existing products on the market.
DSI's consultants work with global regulatory agencies regularly to understand their precise requirements. Its experts offer instrumental advice and strategies to companies that are working on launching a medical device onto the market and can organize the needed registrations or submissions.
Through this challenging process, consultants provide expert advice on the development or revision of a Quality Management System (QMS), identification of gaps, and provide the most recent knowledge on the current versions of regulations, guidance documents, and standards that are relevant to a specific device submission.
Global regulatory requirements are unique to each country and are continually changing. This means it can be challenging to hold current knowledge of every directive or regulation set by individual regulatory bodies.
Hiring consultants with expertise can be beneficial to a manufacturer when it comes to saving 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 as soon as a medical device is approved for use in one or more of these markets.
Medical device consulting with DS InPharmatics
DSI provides various consulting services to assist companies in developing new medical devices, registering devices to new regulations, and devising strategies to help alter existing devices.
The team at DS InPharmatics offers vast experience with global regulations, allowing its consultants to create comprehensive strategies that result in medical device market approvals worldwide.
DS InPharmatics’ medical device services include:
- Medical Device Development Strategies
- Medical Device Regulatory Strategies
- Risk Analysis (FMEA and Hazard Analysis)
- 510(K) Medical Device Application
- Investigational Device Exemption (IDE) and Medical Device Clinical Studies
- Worldwide Regulatory Applications
- Premarket Approval Application (PMA)
- Post-Market Approval Requirements and Activities
Contact DSI’s consultants to learn how its services can support a device being approved to market as quickly and effortlessly as possible.
Acknowledgments
Produced from materials originally authored by Meranda Parascandola at DS InPharmatics.
About DS InPharmatics
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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