Meddev Solutions
Best-in-class Medical Device Regulatory Consultancy Services

As medical device manufacturers combat challenges associated with regulatory and quality requirements, they often find that time is not on their side. Added to that, inadequate expertise and the lack of resources needed to navigate through this regulatory maze of medical device manufacturing hinders the productivity of organizations, as they push toward successful approvals of their devices.

Thus, to ensure all the regulatory requirements of the manufactured products are met, it is essential to work with an organization that has the experience to review and validate the products’ readiness for the market. To that end, a team of skilled Medical Device Professionals—Meddev Solutions—plays a crucial role in offering comprehensive consulting services to companies on a wide variety of subjects ranging from Quality Management Systems, Regulatory Compliance, Technical Documentation, Clinical Data Evaluation, Unique Device Identification, and Risk Management. The combination of both industry and Notified Body experience makes Meddev capable of delivering solutions that are right first time.

Working alongside renowned multinational companies, Meddev fills the knowledge and resource gaps that clients may face in their pursuit of product approvals.“We are actively involved in both MDR and IVDR implementation at several companies; therefore, we are seeing the reality of achieving compliance through different approaches,” adds Rod Beuzeval, Director of Meddev Solutions. Meddev’s team of medical device regulatory consultants routinely train and provide consultancy services to the top medical device manufacturers across the globe. Besides, the team has a minimum of two-decades working experience in the Medical Device industry, working for both manufacturers and Notified Bodies.

Meddev understands that they are essentially the representation of their clients, which is precisely why the company walks the extra mile to develop a thorough understanding of its client’s challenges, coupling it with expert knowledge and best practices to render an effective solution ultimately.

We are actively involved in both MDR and IVDR implementation at several companies; therefore, we are seeing the reality of achieving compliance through different approaches

On one occasion, a company’s C.E. certificate was revoked by a Notified Body. Meddev stepped in to help the client-company get back on their feet by improving their quality management system,such that they could continue selling devices once again. Apart from resolving such impediments, Meddev has published an MDR guidebook that manufacturers can use to aid their MDR implementation projects.An IVDR version of the guide, is currently being worked on, which will be out later this year. For medical device manufacturing companies involved in ensuring compliance with the EU MDR, Meddev’s MDR Guidebook is the ‘go-to’ reference and tool kit. Additionally, the guidebook contains many useful tools and tables for reference, such as medical device classification and their differences from the MDD, how QMS requirements align with ISO 13485, and many more. In addition to the guidebooks, Meddev run courses designed for industry professionals,but are also suitable for anyone inquisitive about EU MDR. These courses can also be run fully online in a ‘virtual classroom’ environment.

Also, working in a close partnership with Comply Guru—an organization offering online training courses—Meddev has started developing a self-paced online training program for clients. The training courses will span across a wide range of subjects beginning with Regulation Basics for Medical Devices, E.U. Medical Device Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), Clinical Data for Medical Devices and MEDDEV 2.7/1 and Application of Risk Management.

Having carved a unique niche in the medical device manufacturing space, there is no stopping for Meddev when it comes to enhancing its competencies. The company is already operating worldwide, having conducted projects across the U.S. and China. The company aims to be seen as the go-to destination for Medical Device Training and Consultancy, while strategically helping its clients make better use of the associated regulations.