Contact us: +49 (0)251 978240-0

Clinical Lifecycle Support
Stronger evidence Smarter compliance Faster market access
An integrated, evidence-based service that aligns Clinical Evaluation, Risk Management and Post-Market Surveillance across the clinical lifecycle of a medical device
More info
Clinical Risk PMS

Regulatory compliance no longer works in silos

Clinical evaluation, risk management, and post-market surveillance must remain continuously aligned. Fragmented approaches increase regulatory risk and slow down market access.

With our Clinical Lifecycle Support Service, we concurrently oversee and address Clinical Evaluation, Risk Management (RM) and Post-Market Surveillance, allowing for complete data integration and traceability through the clinical lifecycle of medical devices.

Clinical Lifecycle Support turns compliance into a connected, structured system.

A single framework. One lifecycle.

Clinical Lifecycle Support is a comprehensive service that ensures compliance with the Regulation (EU) 2017/745 (MDR) and the relevant ISO standards (ISO 14971 and ISO/TR 20416).

A structured and continuous framework that integrates:

A single framework. One lifecycle.

Clinical Lifecycle Support is a comprehensive service that ensures compliance with the Regulation (EU) 2017/745 (MDR) and the relevant ISO standards (ISO 14971 and ISO/TR 20416).

A structured and continuous framework that integrates:

  • Clinical Evaluation
  • Risk Management
  • Post-Market Surveillance (PMS & PMCF)

A single framework. One lifecycle.

Clinical Lifecycle Support is a comprehensive service that ensures compliance with the Regulation (EU) 2017/745 (MDR) and the relevant ISO standards (ISO 14971 and ISO/TR 20416).

A structured and continuous framework that integrates:

  • Clinical Evaluation
  • Risk Management
  • Post-Market Surveillance (PMS & PMCF)

A single framework. One lifecycle.

Clinical Lifecycle Support is a comprehensive service that ensures compliance with the Regulation (EU) 2017/745 (MDR) and the relevant ISO standards (ISO 14971 and ISO/TR 20416).

A structured and continuous framework that integrates:

  • Clinical Evaluation
  • Risk Management
  • Post-Market Surveillance (PMS & PMCF)

From regulatory obligation to strategic advantage

Grafica
Grafica Mobile3
Manufacturer Benefits

Integrated solutions for effortless MDR compliance

Clinical Evaluation

Stronger evidence, faster market access See more

Clinical Evaluation

MDR-compliant clinical evaluations, anchored in MDR Annex XIV, MDR Article 61, the relevant MDCG documents and MEDDEV2.7/1 Rev.4, structured to withstand Notified Body scrutiny thus reducing delays and unnecessary revisions.

Risk Management

Controlled and traceable risk See more

Risk Management

ISO 14971-aligned risk management integrating clinical and PMS insights into a continuously updated risk management file.

Post-Market Surveillance

Continuous real-world oversight See more

Post-Market Surveillance

A structured PMS system, anchored in MDR Annex Ill and XIV, MDR Article 83 - 86, the relevant MDCG documents and ISO/TR 20416; that captures and analyzes real-world safety and performance data and feeds these insights back into the product lifecycle.

Compliance across the entire clinical lifecycle

Unifying clinical evaluation, risk management and PMS delivers transparent, traceable data, smoother regulatory pathways, faster market access, and greater confidence from regulators and customers.

How Our Service Works

Our consultants perform a structured gap analysis of your Clinical Evaluation, Risk Management documentation, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) against the EU MDR requirements, international standards and guidance documents. We assess not only compliance, but how effectively these elements are connected across the clinical lifecycle, identifying regulatory risks, inefficiencies, and opportunities for integration.

Based on the assessment, we design a tailored EU MDR-compliant clinical lifecycle framework aligned to your Quality Management System (QMS). This includes defining clear interfaces between Clinical Evaluation, Risk Management, PMS/PMCF, and vigilance activities, ensuring clinical evidence generation is proactive, defensible, and audit-ready.
Our consultants work directly with your teams to implement the framework. We develop or refine procedures. temolates, and reports, and establish robust traceability between clinical data. risk controls, and regulatory deliverables. This ensures consistency across CERs, Risk Management Files. PMS and PMCE Plans and the Technical Documentation.
We support the active monitoring of clinical and post-market data, applying data-driven methods to detect trends, safety signals, and performance insights. Our consultants help ensure findings are systematically fed back into the Clinical Evaluations, Management Files and PMS/PMCF activities, in line with MDR expectations.
As new data emerges, we support timely updates to Clinical Evaluation Reports, Risk Management Files and PMS/PMCF Reports and risk management documents. Our consultants help you maintain continuos MDR compliance, respond effectively to Notified Body feedback, and strengthen your clinical evidence strategy throughout the product lifecycle.

The power of full integration

Clinical Lifecycle Support is an integrative service that supports medical device manufacturers from initial evaluation through to post-market performance, ensuring compliance, safety, and market confidence from initial clinical evaluation.
Learn how the clinical lifecycle service works.