We are excited to welcome our guest blogger, friend, and expert in the diagnostics industry Terrie Dosenberry. Terrie is the Director of Program Management for Quality Assurance and Regulatory Affairs at Hologic’s Diagnostic Solutions Division based in San Diego, CA. Terrie is currently leading a global cross functional team of technical experts toward implementation of the approaching IVDR.
How do you break down the IVDR proverbial elephant before it breaks you? Take a few deep breaths and pull out the action words; read, train, communicate, collaborate, so you can successfully implement. The IVDR is undoubtedly going to be a significant effort for existing resources and will require more resources to implement and maintain the new requirements. This is a challenging time as notified bodies complete IVDR designation and expectations begin to evolve into best practices. So how do you get started?
Read the text of the regulation. Yes, it’s long and full of legal ease so break it down into sections and get familiar with the layout (Preface, Chapters, Articles, Annexes). This is the blueprint for the remediation effort since there are no other guidance documents, common specifications, or technical specifications available.
Train, as much as possible, to continue to gain an understanding of the regulation. Review the internet for intel from legitimate organizations such as MedTech Europe, EU Commission or your Notified Body.
Communicate across your company to ensure all departments are involved in implementation activities because it requires experts in many areas such as R&D, Clinical, Supply Chain and Supplier & Distributor management, Quality Compliance and Assurance, Marketing and last but certainly not least Regulatory and Labeling. The more actively involved the entire company is the easier it is to implement and maintain the regulation.
Collaborate with consultants, such a Qservegroup, to check your understanding and obtain expert help in turning the regulation into actionable steps and templates for implementation and maintenance. Collaborate with the medical device sector to glean lessons learned and best practices for similar requirements such as post market surveillance, and risk management.
Implement a plan to determine the key aspects of the IVDR such as key milestone dates, what is eligible for the “transition period”, product classification, determine which products require each type of IVDR document, resource needs to complete the required documents and how post market surveillance will be maintained.
The IVDR date of application is fast approaching with less than 2 years remaining. Do not delay your remediation plans. We are all in this together and there are experts ready and willing to help you succeed.
Terrie Dosenberry, PMP
Terrie is the Director of Program Management for Quality Assurance and Regulatory Affairs at Hologic’s Diagnostic Solutions Division based in San Diego, CA. For the past 4 years she has been leading corporate wide projects involving facility consolidation and acquisitions/divestitures. Terrie is currently leading a global cross functional team of technical experts toward implementation of the new European Invitro Diagnostics Regulation. Terrie has more than 30 years of expertise in the Diagnostics Industry holding various leadership positions in Development, Operations, Product Support and Alliance Services. She has a B.S degree in Biochemistry from the University of California San Diego along with a PMP certification in Project Management from the PM Institute.