Medical Device Consulting – FDA Compliance Improvements that Last

Are you looking for help with FDA compliance? You need durable results and that’s what Dorothy Erlanger delivers with her medical device consulting.  As a specialist in FDA compliance, Dorothy provides a proven process with an industry-specific approach for improvements that stay put and efficiencies that last.

Leaders in heavily regulated medical device manufacturing and R&Dgrapple with:

  • Headaches in assuring compliance while achieving operating efficiencies
  • The struggles of diverse teams who must collaborate to get results (stet) but often don’t.
  • Turf wars and internal politics that make you wonder if you’re all working toward the same end goal

Most consultants prescribe software or professional development as the complete solution, leaving clients with a long and complex to-do list – and problems that keep coming back.  In contrast,  Erlanger delivers concrete, facilitated problem solving and mapping, working side-by-side with your teams. When her work is done, you’ll have real accomplishments and ownership for sustainable results.

The Proprietary ProMetRx Process for Medical Device Consulting

Put Erlanger’s proprietary ProMetRx Process to work for your company to get to the root cause and unlock the power across your teams. With ProMetRx, you’ll generate practical solutions and cross-functional commitment, so people work effectively across silos on an ongoing basis. Last but not least, Dorothy works with clients to ensure they finish with a “done” list, not another “to-do” list.

Dorothy will facilitate cross-functional teams around solving specific problems. Her unique process allows teams to self-assess and then identify their own improvements and solutions. Process and metrics are mapped, identifying tough issues and low hanging fruit.

Senior management will be briefed on progress and essential decisions to settle conflicting priorities and move all to common goals of sustaining FDA compliance and achieving operational goals.

To learn more about Erlanger’s ProMetRx and medical device consulting, contact us below.

  • 1-804-749-4100