Validation

Validation, which includes software validation, is a critical and essential part of your design process, within the Quality Management Systems ISO 13485:2003 and the Risk Management ISO 14971 requirements. Validation is a "must have" part of the Technical Documentation needed for CE Marking or 510 (k) regulatory approval of your medical device. Qserve has in house experts with a great deal of experience, who can support and assist you in complying with these regulatory requirements.

Validation is the sum total of processes required to ensure that a medical device (design) will conform to "user needs" and "intended use(s)", given expected variations in components, materials, manufacturing processes and the use environment.

In general, the validation of a process is the mechanism or system used by the manufacturer to plan,
obtain data, record data, and interpret data. These activities may be considered to fall into four phases

• firstly, an initial qualification of the equipment used and provision of necessary services also known as installation qualification (IQ);
• secondly, a demonstration that the process will produce acceptable results and establishment of limits (worst case) of the process parameters also known as operational qualification (OQ);
• thirdly, an establishment of long term process stability - also known as performance qualification (PQ);
• and lastly, Product Performance Qualification (PPQ), which assures that the product complies to all the safety and performance requirements.

Planning for validation begins early in the design process: performance characteristics that are to be assessed must be identified, and validation methods and acceptance criteria identified.

Qserve Consultancy can assist you with site, process, system and product validations. We can identify the requirements for validation specific to your medical device and related processes, and develop suitable validation study strategies and schemes. Qserve Consultancy can source test facilities and also advise you on the timing of re-validation activities. Our services comprise:

• Identification requirements for validation
• Validation planning: Validation Master Plan (VMP)
• Validation protocols: IQ, OQ & PQ (Installation, Operational & Performance Qualifications)
• Validation tools and techniques
• Monitoring and control
• Validation Gap Analysis
• Re-validation

Examples of the types of validation activity we advise on include:

• Clinical
• Sterilization
• Packaging, labeling
• Shelf-life
• Software
• Clean room