医疗设备过程验证顾问
医疗设备实用程序和设备过程验证
Medical device manufacturing process validation is a necessary part for the regulatory agency like US FDA have long introduced the validation process as the significant requirement of quality assurance for medical device manufacturers. Medical device validation process ensures that you have objective evidence that meets the user’s needs and their intended use. It is performed by tests, inspections. Generally, the motive of validation is to make sure that the user’s needs are met in medical devices that consistently provide the intended medical benefits in the actual – use medical conditions. Process validation, as the name implies, focuses on the production of the device. The reason for this is, to satisfy the FDA’s requirements and ensure business success. Prior to presenting another medical device onto the market, makers ought to have a serious level of sureness that their assembling processes have the appropriate controls set up to create items that are protected and meet indicated client, specialized, and administrative necessities.
过程验证定义为整个生产过程中设计阶段过程中信息的收集和评估，这提供了科学证明，即该过程能够始终如一地提供优质的产品。制造商有必要执行医疗设备过程验证。医疗设备设计验证侧重于设备本身，并涉及创建证据表明它满足用户的需求及其预期用途。它是在原型开始之前的第一批生产单元上完成的。质量保证，工程和制造的团队是过程验证的要求。它是在用户的位置完成的，而不是受控的，而是实验室条件。涉及整个包装和标签单元。两项法规（21 CFR第210和211部分）都规定设备和公用事业验证需要在直接产品影响时资格。资格测试为您提供了确保您的设备正常运行，并且符合用户和产品 - 需求规格。
Medical Device Process Validation Services
医疗设备过程验证分为以下小节：
- HVAC validation
- Equipment validation
- Process validation
- Facilities validation
- Cleaning validation
- Analytical method validation
- Personnel validation
- Packaging validation
- Computer system validation
Being a医疗设备顾问, Operon Strategist provides medical device process validation to manufacturers & medical device process validation service providers for the validation activity & documentation. we can also provide guidance on regulatory requirement for the process The product and the production facility are studied to document the validation master plan according to which validation activities will be performed as per the defined timeline. We also guide manufacturers & medical device process validation service providers on the validation activity & documentation. We provide guidance for preparing FDA medical device process validation protocols & reports in the correct format so as to meet the regulatory requirements including IQ OQ PQ DQ protocols & PQ report ,we also provide guidance on EU mdr medical device process validation.