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Clinical Evaluation Procedure

Template Contents

Purpose
Scope
Authority and Responsibility
Terms, Definitions and Abbreviations
Clinical Evaluation
What is a Clinical Evaluation?
Who can conduct a Clinical Evaluation?
Procedure
Stage 0 - Planning
Stage 1 - Identify Pertinent Data
Stage 2 - Data Appraisal
Stage 3 - Data Analysis
Stage 4 - Clinical Evaluation Report
Post-Market Clinical Follow-Up (PMCF)
Clinical Evaluation Updates
Need for Clinical Investigations
Clinical Investigation for Novel devices
Implantable Devices and Class III Devices
Medical Devices without an Intended Purpose
Summary of Safety and Clinical Performance (SSCP)
Records
Applicable Regulations, Standards and Guidance Documents
Associated Documents
List of Attachments
Revision History
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Quickly spot areas for improvement with our Gap Analysis Tool, complete with a consultation to guide your compliance journey.
Cost: £7,000
Who this is for: The Virtual Manufacturing QMS package is appropriate for companies that outsource manufacturing and/or design of their product(s).
What’s included: Each procedure template is designed to meet industry standards, along with guidance notes, and relevant associated forms.
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LFH Regulatory offers an array of services to meet the diverse needs of our clients. Our comprehensive suite of services includes:

Regulatory

The evolving regulatory landscape, including the Medical Device Regulation 2017/745, makes bringing medical devices to market challenging.

Technical File

Risk Management

Biological Evaluation

Regulatory Strategy / Market Access

Regulatory Intelligence (RI) Services

Quality

Ensuring quality is essential in the medical device industry. Patient safety, regulatory compliance, and market success all hinge on the quality and consistency of your medical products.

We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.

Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.

QMS implementation including ISO 13485 & MDSAP

Clinical

Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.

Clinical Evaluation

Performance Evaluation

Global Registrations

LFH Regulatory provides global registration services to help medical device and In Vitro Diagnostics manufacturers navigate international compliance and market access.
We can help with everything from feasibility assessment to effective lifecycle management, as well as integrating a robust quality management system into your business operations.

Global registration services

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LFH Regulatory offers UK Responsible Person and EU Authorised Representative services to ensure compliance with UK MDR 2002 and EU regulations for medical devices.

UK Responsible Person Services

EU Authorised Representatives

Training

Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle. 

We can help with everything from feasibility assessment to effective lifecycle management, as well as integrating a robust quality management system into your business operations.

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