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EU MDR and IVDR Transition and Technical Documentation Compilation

person shuffling through a stack of papersThe one-year postponement of the go-live date of the EU Medical Device Regulation (MDR) has given companies more time to complete their product certifications and refine their systems. Don’t let the extra leeway push you into the procrastination trap—particularly since the EU In Vitro Diagnostic Regulation (IVDR) is still due to take effect in May 2022.

We’ll help you navigate the complex regulations, processes and protocols to achieve regulatory compliance, on-schedule. Backed by proven procedures and tools, our team has extensive experience helping multinational companies with their EU MDR and IVDR transitions and implementations.

Our team of scientific writers will pull together and create the required documentation to ensure you comply with EU MDR, IVDR, and Medical Device Directive (MDD) requirements, including:

  • Clinical evaluation plans (CEP)
  • Clinical evaluation reports (CER)
  • Post marketing clinical follow-up (PMCF) plans and reports
  • Periodic safety update reports (PSUR)
  • Post marketing safety reports (PMSR)
  • EU MDR and IVDR technical documentation

For more information on the EU MDR and IVDR regulatory processes, reach out to our team today.

Resources

Professional calculating medical device finances.

August 22, 2023

FDA Medical Device User Fees (MDUFA) for 2024

On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and...
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5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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