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Medical devices must meet stringent regulatory requirements to ensure patient safety. However, the demand for quicker medical device production makes this a challenge, as compressed timelines allow for more production variance, resulting in subpar outcomes. CQV (Commissioning, Qualification, and Validation) ensures medical devices follow design specifications and operate in accordance with predetermined standards, regulatory requirements, and quality standards throughout their lifecycle. Medical device validation utilizes documented evidence to verify consistent adherence to pre-established quality, safety, and performance criteria, ensuring compliance with regulatory requirements. Through validation, you can:
- Minimize the risk of defects or malfunctions that could compromise patient safety
- Identify and rectify any issues during the development and manufacturing stages
- Comply with regulatory bodies, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
- Obtain documented evidence that your manufacturing processes are consistent and reliable
Medical Device Validation in Three Steps
The medical device validation process is critical for meeting regulatory standards. With this three-step approach, you can reduce costs and shorten project timelines without sacrificing quality or compliance.
- Knowledge share of products, equipment, processes, and any unique requirements.
- Provision of cost-effective, high-quality, and regulatory-compliant solutions.
- Document justification for focused testing to streamline the document development and execution process.
We use a best-practice approach incorporating ISO concepts while helping develop procedures that address other regulatory needs, including:
- Management controls
- Design controls
- Corrective and preventive actions
- Production and process controls
Better Outcomes Start with Better Planning
Performance Validation (PV) offers comprehensive services to ensure the quality, safety, and regulatory compliance of medical devices. When you require process validation, test method validation, or connected device services, trust us to get the job done compliantly.
- Macro validation planning and reports
- Risk analysis development
- Project management (including expense, project, and milestone management)
- Process validation expertise
- Class I, II, and III medical device manufacturing
- New production lines
- Existing production line updates
- Quality system development
- Validation program governing documents
- Corrective and preventative action procedures
- Production and process control procedures
- FDA remediation
- Form 483 response and completion
Process Validation Services that Meet Compliance
PV not only develops and executes high-quality operational and performance qualification (OQ/PQ) protocols, but our team also assists with design of experiment (DQ) and testing strategies. We work to understand, document, and test your manual, automated, and special processes for compliance.
- Laser marking
- Laser, ultrasonic, and resistance welding
- Adhesive curing
- Soldering
- Packaging
- Injection molding
Reliable Test Method Validation Services
PV recognizes the need to ensure a test method is suitable for its intended use. We work with quality systems to develop a sampling plan and acceptance criteria before statistically analyzing results.
- Tensile testing
- Compression testing
- Automated measurement systems
- Visual inspection
Quality System Regulation (QSR) Support
When you need quality system regulation (QSR) support for medical devices, trust our team to deliver satisfactory results. Get help developing, implementing, and maintaining quality management systems that follow the regulatory requirements outlined in the QSR. Auditing processes or elements we’ve helped refine include:
- Validation program governing documents (e.g., production equipment qualification, facility qualification, process validation, cleaning validation, computer system validation, analytical equipment qualification and methods qualification)
- Supplier assessments of new or current vendors
- Qualification and validation packages
- Design history file
- Change control
- Batch record reviews
Improving Patient Safety Through Connected Device Services
Connected medical devices are already entering everyday life, bringing the potential to deliver better patient care and improve operational efficiency. Medical device connectivity can help provide healthcare professionals with complete, accurate and current patient assessments on demand. At PV, we understand the importance of patient safety and offer Computer Software Validation and Software as a Medical Device (SaMD) solutions. Our team also has experience in validating artificial intelligence (AI).
Your Dedicated Partner for CQV Pharma Services
PV supports Fortune 500 companies, foreign subsidiaries and smaller medical device companies with their medical device validation needs. Let us help you define equipment requirements, installation qualifications, and final assembly processes to ensure compliance with industry regulations and standards.
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