Medical Device Process Validation Consultant

Why Are Medical Device Utilities and Equipment Validation Required?

The medical device validation process ensures that medical devices that are manufactured will perform safely and appropriately. The regulatory bodies are setting a few standards for the validation and verification of the devices. As medical device regulatory consultants, we provide guidance to create validation reports as per regulatory requirements. 

What Is the Difference Between Process Verification and Validation?

When a manufacturer plans to introduce a medical device in the market, they should have a high degree of certainty that their process has proper control while producing the products and they meet the specified regulatory criteria. The USFDA and ISO 13485 require manufacturers to verify their product meets the design specifications and this can be accomplished by testing or inspecting it. This is actually a verification process that means verifying the quality of the product but testing every single device is impractical, and process validation comes into the picture. The process validation completes the quality assurance need. As an ISO 13485 medical device consultant We know the guidelines provided by the standard and we help manufacturers to implement them correctly.

According to USFDA process validation means establishing the objective evidence that a process consistently meets the product’s Predetermined specifications. 

Why Do Medical Device Manufacturers Need a Validation Process?  

Medical device manufacturing process validation is a necessary part of regulatory agencies like the US FDA which has long introduced the validation process as a significant requirement of quality assurance for medical device manufacturers.  

• The 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 and 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. 

How Is the Process Validation Done by Medical Device Consultants?

Process validation is defined as the collection and evaluation of information from the process of the design stage throughout the production, which gives scientific proof that this process is capable of consistently delivering quality products. Medical Device Design validation focuses on the device itself and involves creating evidence that it meets the user’s needs and their intended uses. It is done on the first batch of production units after the prototype, that is before the mass production of the unit begins.  

A team of Quality assurance, engineering, and manufacturing is required for process validation. It is done at the user’s place and not controlled but the lab conditions. The entire unit of packaging and labeling is involved. Both regulations, 21 CFR Part 210 and 211, specify that the Equipment and Utilities Validation requires qualification when they have direct product impact. Qualification testing provides you with the assurance that your equipment is operating properly and meets both the user and product – requirement specifications.