Classing medical devices

In the EU all medical devices must be issued with a Certificate of Conformity, by a Notified Body (in Ireland the IMB). Various risk classes:

High risk (similar to Class I – USFDA): used in critical care, whose failure is likely to seriously injure the patient or staff. Examples include incubators and aspirators

Medium risk (similar to Class IIa/b – USFDA): These are devices including many diagnostic instruments whose misuse, failure or absence with no replacement available would have a significant effect on the patient, but would not be likely to cause direct serious injury. Examples include: ECGs or endoscopes.

Low risk devices (Similar to Class III – USFDA): Devices in this category are those whose failure or misuse is unlikely to result in serious consequences. Examples include: surgical microscope or breast pumps.

Key Acronyms

IQ/OQ/PQ              Installation Qualification, Operational Qualification, Performance Qualification

GHTF                     Global Harmonization Task Force

STED                     Standard Technical Documents

CAPA                     Corrective Action and Preventive Action

Job Areas

Various Medical Device Engineering positions

-Quality. Deals with most of the above, also customer complaints. Degree of hands-on responsibilities can vary between company to company

-Validation: similar to Validation in the Pharmaceutical field, with various equipment being validated

-Research and Development (R&D) Engineering: concerns the various stages of R&D engineers, from concept to prototype, working through to the final product to be approved. Also important when considering new applications to current approved devices or making alterations.

Within these areas there are smaller, more niche engineering vacancies, such as moulding engineers, quality systems engineer, customer complaints engineers, environmental, health and safety (EHS) engineers, regulatory affairs.

-Brian (bhc at lifescience dot ie)