Navigate Regulation, Demonstrate Safety, Accelerate Access

The medical device and in vitro diagnostic industry is navigating one of the most significant regulatory transitions in its history. The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have fundamentally raised the bar for market access, clinical evidence requirements, and post-market obligations — creating both compliance pressure and strategic opportunity for companies that plan ahead.

PLG’s MedTech team combines regulatory expertise with deep knowledge of MDR and IVDR frameworks to support device and diagnostic companies through every phase of the product lifecycle. From initial regulatory strategy and technical documentation through quality management system design, clinical evaluation, and post-market clinical follow-up, our specialists work alongside your teams to ensure your products meet European and international requirements efficiently and sustainably.

Success in today’s MedTech environment demands more than regulatory compliance — it requires proactive evidence generation, robust quality systems, and the ability to turn post-market data into actionable insights that support continuous improvement and regulatory dialogue. Our goal is to help you maintain market access, protect your product’s position, and build the foundation for long-term commercial success.

Our 5 MedTech services — Medical Device and MedTech Services, MDR & IVDR Compliance, Quality Management Systems, Post-Market Surveillance, and Clinical Evaluation & PMCF — are designed to work as an integrated offer or to complement your existing capabilities where specialist support is needed most.

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Medical device and medtech services

Comprehensive regulatory and development support across the product lifecycle, from concept through commercialization and beyond.

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MDR & IVDR compliance

Expert guidance navigating MDR and IVDR requirements, ensuring compliant transitions and sustained market access.

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Quality management systems

ISO 13485-compliant QMS design, implementation, and optimization tailored to your organizational needs and regulatory requirements.

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Post-market surveillance

Structured PMS systems that meet regulatory obligations while generating actionable insights for product improvement and risk management.

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Clinical evaluation & PMCF

Rigorous clinical evaluations and post-market clinical follow-up strategies that demonstrate ongoing safety and performance.

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Frequently asked questions

Five services: Medical Device and MedTech Services, MDR & IVDR Compliance, Quality Management Systems, Post-Market Surveillance, and Clinical Evaluation & PMCF. They can work as one integrated offer or complement your existing capabilities where specialist support is needed most.

PLG assesses your portfolio against MDR or IVDR requirements, defines the transition strategy and builds or updates technical documentation, clinical evidence and quality systems. The aim is a compliant transition that maintains market access, including during the extended transition periods, which apply only if specific conditions are met.

The Medical Device Regulation (EU) 2017/745 covers medical devices, while the In Vitro Diagnostic Regulation (EU) 2017/746 covers diagnostic tests performed on samples taken from the body. Both raised requirements for clinical or performance evidence, Notified Body involvement and post-market obligations compared with the previous directives.

Yes. PLG designs, implements and optimises ISO 13485-compliant quality management systems tailored to your organisation, product classes and target markets. It also supports gap assessments, internal audits and preparation for Notified Body or authority audits.

A clinical evaluation is the structured assessment of clinical data showing that a device is safe and performs as intended. Post-market clinical follow-up (PMCF) continues to collect clinical data once the device is on the market. Under the MDR, PMCF is expected for most devices unless a justified rationale shows it is not needed. PLG prepares both.

Post-market surveillance (PMS) is the system a manufacturer uses to monitor device performance and safety after launch, including complaints, trends, vigilance reporting and periodic reports. PLG sets up structured PMS systems that meet regulatory obligations and turn post-market data into insights for product improvement and risk management.

Yes. Alongside EU MDR and IVDR expertise, PLG supports device and diagnostic companies with international requirements, drawing on a presence in 50+ offices and coverage of 150+ countries. This helps manufacturers plan multi-market strategies from the start rather than adapting documentation country by country.