Qualification and validation ensure the quality of medical devices

We provide qualified equipment and validated manufacturing processes that ensure reproducible high quality of medical devices.

Medical device manufacturers must ensure that their medical devices meet high quality standards to satisfy regulatory requirements and protect patients. It is therefore advisable to comply with these requirements already during development and to consider them in all further process and manufacturing steps.

After successful design verification and design validation, during which we can advise and accompany you, manufacturing the medical device is the next hurdle. Manufacturers must ensure that the quality of the product is reproducible.

Our experts will be happy to help you overcome this challenge.

Requirements for medicinal products

In addition to the qualification of the manufacturing facilities and quality control equipment, Din EN ISO 13485, MDR 2017/745, IMDRF and FDA, require the validation of the associated processes.

However, the implementation of validation and qualification is often only performed to a certain extent. Either the medical devices are manufactured with unqualified equipment, or the manufacturing processes are not validated. A lack of resources and the extensive and costly scope of qualification and validation are among the main reasons.

Our experts take a process-oriented (definition of the relevant process steps) and risk-based approach (process risk analyses, technical risk analyses) to ensure a time-efficient and cost-effective process. All critical aspects related to the medical device classes are addressed, while keeping the scope for qualification and validation to a necessary minimum.

Depending on the planned application, other current standards such as GMP rules must be applied during qualification. Medical devices scheduled to be approved in the U.S. must meet the requirements of the FDA. In this case, qualification must be executed in accordance with 21 CFR 820.1 cGMP (current Good Manufacture Practice). In addition, the use of GMP regulations is also recommended for combination products (drugs with medical devices).

How we can support you

Valicare offers services ranging from the execution of individual subtasks to superior project management and complete execution of qualification and validation. Many projects start with recording the target/actual state (gap analysis) to define the gaps and the upcoming tasks. We have comprehensive qualification and validation concepts ready for you.

Our services include:

• Listing of all process steps and creation of a process risk analysis
• Preparation of a validation master plan
• Preparation of technical risk analyses
• Initial qualification plans for facilities and equipment

• Implementation of the qualification (DQ, IQ, OQ and PQ)
• Preparation of validation plans (design, process, cleaning, method, and computer system validation)

We will be happy to advise you and to work with you to create the optimal quality concept for the production of your medical devices.

Further services for DIN EN ISO 13485 compliance and quality risk management for medical devices can be found here: Medical Device Compliance.