Medical Devices and Their Complex Regulatory Environments

Medical Devices and Their Complex Regulatory Environments

Medical device development is a challenging environment filled with complex manufacturing, life-cycle management and regulatory remediation to comply with Food and Drug Administration (FDA) standards.

Even the most comprehensive plans can fall short of meeting the FDA’s Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards. The world’s largest and most successful device companies depend on The Evanston Group’s experienced consultants to assist with a full range of development, manufacturing and regulatory matters. Organizations that partner with The Evanston Group obtain access to consultants who are uniquely qualified, know the FDA and have handled every type of case imaginable.

Year after year, Evanston has deep involvement with the most important projects at the world’s largest life science companies, making the firm uniquely qualified to address a broad range of issues.

Consider the predicament of a global multi-billion-dollar device company. They found themselves dead in the water until they could satisfy a FDA consent decree which prohibited the sale of their devices, as well as the development of upgraded products. The Evanston Group brought in a team of industry-leading project managers and SMEs to swiftly identify the pain points, propose a resolution, communicate those actions to the FDA and see the job through to successful completion.

Within five months, the team closed 1,906 compliance gaps in the supplier management database and over 159 supplier audits, as well as implementing new corporate supplier procedures. As part of the project, The Evanston Group’s team unearthed six additional compliance gaps and offered solutions before they emerged as further trouble spots.

The remediation plan and subsequent FDA clearance allowed the company to get back to business in a timely manner, which saved an estimated $200 million in product recalls and other expenses. The plan also yielded a pathway for the company to resume its efforts to introduce new products to the marketplace.

In another case, The Evanston Group provided a team of a half-dozen project managers and experts to execute a quality improvement plan that resolved a 483 Warning Letter regarding an electronic infusion device. The multi-work stream leaders quickly examined and documented the gaps, proposed a comprehensive remediation plan and took corrective and preventative actions that addressed the FDA’s concerns.

The Evanston Group is also positioned to help companies meet the biggest changes in European medical device regulations in decades. Revisions of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) fundamentally change the system to?control and identify medical devices. These modifications place pressure on device companies to revise their labeling and packaging in ways that make the EU MDR/IVDR equivalent to the life-cycle approach promoted by the FDA. The new EU requirements call for clear accountabilities, standard processes and data, and technological advances.

The Evanston Group’s network of highly experienced multidisciplinary teams help bring your labeling processes and systems into compliance. The team can also help prepare for the introduction of a new European Database for Medical Devices (EUDAMED), which is the single biggest catalyst of labeling challenges.