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Risk Management Procedure

Template Contents

Purpose
Scope
Authority and Responsibility
Terms, Definitions and Abbreviations
Procedure
Introduction
Process Review
Risk Management File
Planning
Risk Analysis
Intended Use and Reasonable Foreseeable Misuse
Device Characteristics and Hazardous Situations
Risk Estimation
Risk Evaluation
Probability Index
Severity Levels
Acceptability Matrix
Risk Control
Implementation
Residual Risk Evaluation
Benefit-risk Analysis
Risks Arising from Risk Control Measures
Completeness of Risk Control
Evaluation of Overall Residual Risk
Risk Management Review
Change in Design/Process
Post-Production Information
Information to Collect
Information Review
Actions
Applicable Regulations, Standards, and Guidance Documents
Associated Documents
List of Attachments
Revision History
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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:

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

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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.

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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

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

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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.

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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.

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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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