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Software Design & Development Procedure

Template Contents

Purpose
Scope
Authority and Responsibility
Terms, Definitions and Abbreviations
Process
Design Review Meetings
Concept Phase
Feasibility and Planning Stage
Intended Purpose
Software Development Plan
Software Safety Classification
Configuration Management
Agile Definitions
Requirements
Product Requirements Hierarchy
Verify Requirements
Software Architectural Design (SAD)Technology Assessment and Prototyping
Risk Management
Feasibility and Planning Phase Review
Software Development Phase
Planning
Requirements
Design
Risk Management
Software Implementation and Integration
Review
Software Testing
Verification
Validation
Release Notes
Deployment
Maintenance
Operation
Monitor
Respond
Decommission
Problem Resolution
Applicable Regulations, Standards, and Guidance Documents
Associated Documents
List of Attachments
Change History
Appendix – 62304 Documentation requirements
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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.

Technical File

Risk Management

Biological Evaluation

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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.

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

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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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