Medical Device Testing Service, Methods and Standards and Procedures
MET’s service for medical device testing delivers your regulatory requirements according to a wide range of agreed standards, methods and protocols.
Our laboratories are driven by a strict adherence to quality and exacting attention to client requirements.
We at Medical Engineering Technologies we have systematised our work programmes to maximise efficiency and accuracy, and most importantly to comprehensively deliver the information required by you, the client.
At the time of quoting we will review ISO standards along with national guidance(s), to rapidly plan a method of testing for the medical device or delivery system (often conducting a risk analysis). The next stage in the process is the development of a protocol with the client. We have many standard procedures which can reduce the required time to hours, particularly in the case of packaging validation and wound dressing test protocols.
Your purchase order is the contract for the work to progress. Once this is in place, we will deliver the protocol for your approval. If the samples are at MET testing normally commences within a few days of the method approval. A project plan is issued on receipt of the samples (this we very nearly always adhere to) and a draft report issued following testing to allow the client to verify batch numbers and product descriptions. Regular updates are provided for extended projects. The final report is your gateway to regulatory approval.