Post Market Clinical Follow-Up (PMCF) Surveys

The PMCF survey experts

The level of regulatory requirements across the medical device industry has skyrocketed in recent years with the introduction of the European Medical Device Regulation (EU-MDR). There is an increased need for clinical data and evidence collection resulting in higher expectations for Post Market Surveillance (PMS).

What is a solution to these requirements? Enter, Post Market Clinical Follow-Up (PMCF).

Purdie Pascoe is the PMCF survey excellence partner for you. We have developed a best-practice approach, approved by EU regulators and compliant with GDPR regulations, for PMCF surveys. Our dedicated team has implemented and executed over 400 surveys across the last five years, collecting both Level 8 and Level 4 PMCF data.

We can support you with the design, implementation, data collection and reporting of your PMCF surveys to ensure you collect appropriate PMCF data and can comply with Medial Device Regulations.

Why conduct PMCF Surveys?

PMCF requires manufacturers to proactively assess the safety and performance of their devices, once on the market, and record this data throughout the product’s lifecycle. Although clinical investigations and registries provide higher levels of evidence, they may not be necessary for certain devices.

PMCF surveys require less work, money and time, while providing high quality data to confirm the safety and performance of your devices and/or fill any specific clinical gaps.

Why work with us?

  • Specialist team

    Dedicated pool of experts delivering best in class and compliant PMCF survey solutions

  • 400+ PMCF surveys completed

    High-quality case specific surveys (Level 4)
    General end-user surveys (Level 8)

  • Device expertise

    In-depth experience across a wide range of device types and risk classifications

  • Quality and compliance

    Robust compliance and quality assurance protocols in accordance with ISO 9001, Quality Management System and ISO 14155

Find out about the PMCF team

Services

  • PMCF Survey Planning & Design

  • PMCF Survey Programming

  • PMCF Survey Data Collection

  • PMCF Survey Data Analysis / Reporting

Our PMCF Survey Process

Proactively assessing the safety and performance of your medical device continuously throughout the product’s lifecycle.

The Outcomes:

  • Confirm safety and performance

  • Identify unknown side-effects

  • Identify and analyse emergent risks

  • Ensure the continued acceptability of the benefit-risk ratio

  • Identify possible systematic misuse or off-label use

Recent Insights:

Featured
Bias in Medical Device Research: New Considerations for PMCF Surveys
Bias in Medical Device Research: New Considerations for PMCF Surveys

In the first blog of our PMCF Insights Series, Hemant Mistry and Matthew Hanson explore different types of bias in medical device research, the measures being taken to address these issues, and how Purdie Pascoe's deep expertise helps eliminate bias in PMCF surveys.

Read More →
How we collected Level 8 PMCF data for our client's legacy Class I syringe for their EU-MDR submissions
How we collected Level 8 PMCF data for our client's legacy Class I syringe for their EU-MDR submissions

A leading medical device manufacturer required Post Market Clinical Follow-Up (PMCF) data for their legacy Class I syringe. This clinical evidence was needed to comply with PMCF data collection under the EU-MDR. Find out how our PMRC survey approach strengthened the regulatory compliance for their device.

Read More →
Spotlight on Post Market Clinical Follow-Up Surveys
Spotlight on Post Market Clinical Follow-Up Surveys

Marcus Torr provides about his perspective about the importance of PMCF Survey implementation for medical device EU-MDR submissions. He reveals why medical device manufacturers should consider PMCF surveys, how to overcome challenges, solutions for a best practice approach and what makes Purdie Pascoe’s specialist expertise unique.

Read More →

Want to partner with us for your next PMCF survey?
Get in touch.

  • "I very much appreciated the recruitment efforts. I truly felt like the team went above and beyond to exhaust all avenues. I was also very happy with the country justification slides provided for this project. It will be extremely helpful when preparing reports for our notified body."

    Senior Clinical Research Specialist

  • “Our experience with Purdie Pascoe has been exceptional. All tasks were finished on time and to the highest quality”

    Manager, Regulatory Affairs

  • "It has been a pleasure working with Purdie Pascoe. You are always available, have the solutions and answers."

    Medical Affairs Manager

  • "The communication with Purdie Pascoe has been great. You made it very easy to work on the 6 separate devices within the survey."

    Senior Clinical Project Manager

Purdie Pascoe: The PMCF survey experts

The Purdie Pascoe Team
Marcus Torr, PMCF / MDR Lead
Marcus Torr, PMCF / MDR Lead

Marcus joined Purdie Pascoe in 2015, with a First Class MSci in Natural Sciences (Chemistry with Pharmacology) from the University of Bath.

Since joining he has rapidly gained experience and skill in quantitative research and has led, and grown, the PMCF team at Purdie Pascoe for the last four years, who provide PMCF survey solutions to the medical device industry to ensure EU-MDR compliance.

He has extensive knowledge in the specific requirements surrounding PMCF surveys, having overseen over 400 surveys for several of the leading global Medical Device manufacturers across a variety device types. These surveys have been approved by several of the leading Notified Bodies and consist of both end user general surveys and high-quality patient specific surveys.