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Quality Standards


 

LRE develops and manufactures medical IVD devices to the highest technical demands of its OEM customers in compliance with DIN EN ISO 13485 and FDA 21 CFR Part 820 for Class I through Class III medical IVD devices. Structuring and observing the processes and documentation required in these directives does not only mean conformance to legal requirements, in fact they guarantee an efficient development and manufacturing process.

The implementation of the processes allows a transparent and on schedule accomplishment of the individual development phases including transfer to production and manufacturing.

We distinguish between:

General Provisions

 

  • Quality Management Handbook
  • Engineering Handbook
  • Master Validation Plan
  • Risk Management Handbook
  • Change Control Management

Technical Guidelines (Standard Operation Procedures)

 

  • Software: IVD Development Guideline, Style Guide, Configuration Management
  • Electronic Hardware: IVD Development Guideline
  • Mechanical Design: IVD Development Guideline
  • Production: IVD Process Descriptions

Project Specific Operating Sequences and Records

 

  • Product Requirement Specification
  • Project Development Plan
  • Master Validation Plan
  • Risk Management File
  • Technical File (Design History File)
  • Device Master Record (DMR)
  • Verification Reports
  • Assembly and Test Instructions (Design Transfer Documents)
  • Release Documents
  • Review Records
  • Project Progress Reports (monthly)

Quality Assurance

The LRE QA Department routinely audits the processes implemented by LRE as well as the processes required by the external certification body (TÜV-PS) and FDA.

 

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