Medical Device Manufacturing...

Information & Training. | Medical Devices

Due to the critical nature of Medical Devices, there are strict regulatory requirements in terms of validation, which need to be adhered to when developing, manufacturing and releasing a medical device. In addition to all legally required imposed regulatory requirements, a Medical Device development and manufacturer will want to ensure that any device placed on the market, achieves the highest quality and reliability standards and performs as intended in the eyes of the end users, be they medical staff or patients.

What do you need to consider when validating a Medical Device ?

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
EU Medical Device Regulation and Classification (per MDD’s).
^NewEuropean Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>

Validating a Medical Device – The first step to is confirm the device status.

The first task is to confirm that the product is indeed a Medical Device. Per the FDA, a product falls under the definition of a Medical Device if it is intended for use in the treatment, diagnosis or prevention of a disease or some other health condition in humans. Similarly, depending on the planned market for your product, you need to confirm the product status under the relevant national regulatory regime, e.g. in the European Union, confirm the product status against say the Medical Device Directive, similarly for Australia, New Zealand, Canada, etc…

Device Classification.

Once the product is confirmed as a Medical Device, you then need to Classify. When classifying, always remember that the intended purpose is key. A product may have multiply purposes, but what medical condition are you intending to market the product as addressing. Maybe at some later date, the indications for use will be changed, if so, then the classification may change. In each jurisdiction (US, Europe, Australia, Brazil, etc) the classification rules vary, so again, you will need to classify against the particular requirements of each regulatory regime.

Validating a Medical Device must be based on Device Risk.

Through the full cycle of device development, clinical testing, manufacture, release and in-use tracking, a risk assessment and management process will need to be implemented. The risks identified will feed into design improvements, changes in the method of manufacture, changes in the indications for use, improvements in medical and patient training (where applicable).

Good Manufacturing Practices (GMP’s).

The design, manufacture, release of the device will need to be completed under Good Manufacturing Practice requirements. For product which will be sold in the USA, this requires compliance with US FDA CFR 21, in Europe compliance will need to be in accordance with the applicable Medical Device Directives.

Life Cycle Validation.

The relevant national regulations will require that there is Validation performed throughout the design, manufacturing, release stages. Many organisations implement a life cycle approach to Validation. In this approach, you follow a path such as i) defining functional requirements ii) defining the system specifications iii) performing an installation qualification iv) an operational qualification v) a performance qualification and define the plan for on-going revalidation.

Quality Management System.

The Quality Management System will need to effectively implement all the necessary elements such as Change Management, Document Control, Training, Records identification and maintenance, Internal Audit program, Corrective and Preventative Action process, etc..

Traceability and Complaints.

While inherent in the regulatory and quality system requirements, these are important enough to briefly stress. Depending on the classification of the medical device, good effective Traceability and Complaint processes will be critically important. Complaints can be seen as negative, however, if used as a valuable source of real data, can be a genuine source for on-going product and process improvement.

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^NewEuropean Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>

Reference Sources:
US FDA Process Validation – General Principles and Practices >>>
International Medical Device Regulators Forum (IMDRF) >>>