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Process, Tests Methods and Software Validations

Alongside verification, qualification and validation are essential quality management tools for medical device manufacturers. However, their implementation tends to cause uncertainty, particularly among small producers. Questions frequently arise as to the exact circumstances in which these tools should be applied, and how the processes surrounding qualification and/or validation work in practice. Unlike the verification, the procedure of qualification and validation is more complex. In many cases, there is some uncertainty of how these methods are defined and can be distinguished

Verification

Verification is the documented proof that a product meets the specified requirements during development.

Qualification

Qualification is usually performed at facilities, instruments, production plants and QC labs, when they are relevant for the quality of the medical device. It is the documented proof, that the object to be qualified is suitable and safe for the intended use. A qualification consists of a DQ, IQ, OQ, and PQ:

  • Qualification begins with the DQ (Design Qualification), which is performed before purchase to prove that all user requirement specifications are covered by the vendor’s system specifications.
  • The IQ (Installation Qualification) proves that the delivery including all documents is complete and has been properly set up and connected.
  • The OQ (Operational Qualification) is a testing procedure ensuring that every single function, including safety and alarm measures, operates properly.
  • The PQ (Performance Qualification) is the final part of the qualification process, providing evidence, that the intended operation can be performed and reproduced within the specified limits for the complete area of operation.

Validation

Validation is the documented proof that the object to be validated performs in line with the required reliability during practical operating conditions. In the context of medical devices, validation applies to the following areas:

  • A process validation is performed at the production plant and is necessary if not all potential risks are covered by the quality control.
  • The tests method validation is required if non-standard methods are used for  in process controls or quality control.
  • The medical device itself needs to undergo a design validation. This includes clinical evaluations, performance evaluations and usability tests.

Software Validations and CSV

Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality, and details a recognised standard for computer system validation (CSV). GAMP 5 ® is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated or computer systems, in the pharmaceutical industry. This is also now being adopted as suitable guidance for the Medical Devices industry.
One of the core principles of GAMP is that quality cannot be tested into a batch of product or device, but must be built into each stage of the manufacturing process.
As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. Electronic Signatures and Electronic Records (ERES) are also covered in GAMP 5.

Medical Device Software

Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. 

A Software is considered a medical devices when it has a medical purpose on its own to be qualified as a medical device software (MDSW). It should be noted that the intended purpose as described by the manufacturer of the software is relevant for the qualification and classification of any device. In order to be qualified as medical device software, the product must first fulfil the definition of software according to this guidance and the definition of a medical device according to Article 2(1) of Regulation (EU) 2017/745 – MDR. To be qualified as an in vitro diagnostic medical device software, the product must additionally fulfil the definition of an in vitro diagnostic medical device according to Article 2(2) of Regulation (EU) 2017/746 – IVDR. Where a given product does not fall under the definition of a medical device, or is excluded by the scope of the Medical Devices Regulations, other Community and/or national legislation may be applicable. Software that does not meet the definition of a medical device or an in vitro diagnostic medical device (i.e. software that is not MDSW) but is intended by the manufacturer to be an accessory for a medical device, or an in vitro diagnostic medical device, falls respectively under the scope of the Regulation (EU) 2017/745 – MDR or Regulation (EU) 2017/746 – IVDR. Software can directly control a (hardware) medical device (e.g. radiotherapy treatment software), can provide immediate decision-triggering information (e.g. blood glucose meter software), or can provide support for healthcare professionals (e.g. ECG interpretation software).

The type of interconnection between the MDSW and the device (e.g. embedded systems, wires, Wi-Fi, Bluetooth) does not affect the qualification of the software as a device under the MDR and IVDR (e.g. whether the software is incorporated in a device or is at a different location). However, MDSW can be placed on the market in two different ways: as a medical device or in-vitro diagnostic medical device in its own right or as an integral component or part of a hardware device.

MDSW placed on the market as a device or put into service in its own right shall undergo an appropriate regulatory process that shall take into consideration the qualification, classification and intended purpose of the MDSW.

How can we help?

We can help you to successfully integrate qualification and validation methods in your quality management system and to identify equipment and processes that are subject to mandatory qualification or validation, or that may benefit from validation activities for quality reasons or due to strategic considerations. We cooperate with production and quality management experts in your company to work out a customized validation plan based on the specific requirements of your business. If required, we can advise you on how to implement your quality management system and help you prepare the relevant implementation documents.

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