In the dynamic and highly regulated world of medical device development, ensuring the safety, efficacy, and reliability of medical devices is paramount. Our comprehensive design validation and verification (V&V) services provide an essential framework to confirm that medical devices meet all design specifications and regulatory requirements. Our expertise spans the full lifecycle of medical device development, ensuring that your products are not only compliant but also meet the highest standards of quality and performance.
Understanding design validation and verification
Design verification is the process of determining whether the design of a medical device meets the intended use and user needs. It focuses on the design and development of a medical device and whether the device operates as intended and meets its design specifications. Verification testing is typically performed during the development phase of a device and verifies its intended use.
Design validation is the process of confirming that the design outputs meet the design inputs. This testing focuses on evaluating the performance and effectiveness of a medical device and demonstrating that the product functions as intended and meets the needs of the end user. This is typically performed after the device has been completed in a real-world scenario to validate the functionality of the medical device.
Our V&V services
| Requirements Analysis | Comprehensive review and documentation of user needs and regulatory requirements. Detailed requirements specification development to ensure clarity and testability. Alignment of requirements with applicable standards. |
| Design Verification | Systematic testing to ensure the design outputs meet the design inputs. Execution of rigorous testing protocols including unit testing, integration testing, system testing, and regression testing. Use of advanced simulation and modeling tools to predict device behavior under various conditions. Documentation of verification activities by regulatory standards. |
| Design Validation | Confirmation that the device meets user needs and intended uses in real-world conditions. Clinical evaluations, usability testing, and field trials to gather performance data. Risk analysis and management, including Failure Modes and Effects Analysis (FMEA). Compilation of validation reports demonstrating compliance with regulatory requirements. |
| Regulatory Compliance | Assistance with regulatory submissions including 510(k), PMA, CE marking, and other global regulatory pathways. Ensuring alignment with Quality System Regulations (QSR). Preparation and maintenance of Design History Files (DHF) and Device Master Records (DMR). |
| Post-Market Surveillance | Ongoing monitoring and analysis of device performance post-launch. Management of customer feedback, complaints, and adverse event reporting. Implementation of corrective and preventive actions (CAPA) as required. |
Our standardized test methods
Protheragen-ING Lab offers a wide range of standardized test methods, including but not limited to:
- ISO 11608-1 (Needle injection systems).
- ISO 10555-1 (sterile and disposable catheters).
- ISO 7886-1 (Sterile and disposable syringes).
- ISO 11040-4/ISO 11040-5/ISO 11040-6 (prefilled syringes).
- ISO 20697 (Sterile disposable drainage catheters and attachments).
- ISO 11070 (Sterile disposable intravascular introducers, dilators and guidewires).
- ISO 9026 (Stainless steel syringes for the manufacture of medical devices - Requirements and test methods).
- In addition to providing test methods that comply with international standards, we also support our customers in developing customized test methods to meet specific product requirements.
Applicable medical devices
Applicable types of medical devices include, but are not limited to:
- Catheters
- Delivery systems
- guidewires
- Auto-injectors
- Inhalers
- Insulin Pumps
- Ventilators
- Blood Oxygenator
- Pre-filled syringes and needles
- Endoscopes & Endoscopic Accessories
Contact us today to learn more about how we can support your development process and help you achieve regulatory compliance.