Validation Consultants

Medical Device Consultants – Engineering

Medical Device Consultants

Engineering related medical device consultants can come from a lot of different areas. These span from science degrees like microbiology and physics, innovation degrees such as product design and implant design and also a range of engineering degrees – primarily mechanical and biomedical.

There are different grades of Medical Devices depending on the region you are in. In the United States the Grade are I, II, and III. Japan has a fourth grade, Grade IV. In the European Union there are 4 grades also but Grade II is broken into IIa and IIb (I, IIa, IIb & III).  All these grades create a spectrum of different devices that span from sterile gloves and bandages to long term implantable devices such as stents, valve replacements and artificial hips.

The principals of medical device manufacturing are very similar to medicinal products and a lot of the tools used will be the same. GMP is essential in both, and the quality systems involved aim to ensure quality is built into the product along the way. Like medicinal products, manufacturing and product issues will be investigated through non-conformance reports, Corrective and Preventive Action (CAPAs) and the Root Cause Analysis (RCA) will ensure that problems are addressed, and that the frequency of an issue is reduced, if not eliminated completely. It would come as no surprise that this key quality processes, CAPA and RCA are hot citation areas. See the FDA common citations.

Product complaints are monitored and trended to establish if there is an increased risk to the patient and then actions are taken to put the patient’s best interests first. All changes to product or processes need to be controlled through strict change control processes.

For medical devices the product development process needs to be documented completely from initial prototyping and device iteration up to successful market release and even post market surveillance activities. Medical Devices need to be built in accordance with a strict quality management system ISO 13485 and the documentation, from Design History Files to Device History Records, will include the initial usability assessments and all product testing records. For medicinal cannabis the whole process needs to be documented from initial propagation, germination and cloning stages up to warehouse storage and dispatch.

Medical device engineers need to complete Design Validation at the end of Design Verification to ensure that the user needs and intended use of the device are met.  Every manufacturing work step needs to be validated. These work steps could be a glue bond, a tissue cutting technique, a suturing work step for a heart valve and any visual inspection that ensures an operator rejects/accepts the correct units with statistical significance. Within medicinal cannabis every work step and critical equipment needs to be validated.

One of the most important aspects in the product development process is statistics. Statistics are used to justify the number of units that will be built and tested for design verification and design validation activities. These numbers are incredibly important for many reasons but one of the main reasons is that the number of units tested is determined by the Risk Index for each product specification. The risk index for a product specification is obtained from the Risk Management documents, primarily the DFMEA (Design Failure Mode and Effect Analysis), and it is based on both the severity of a harm to a patient, and the occurrence. If the risk index is high many units need to be tested to ensure that there is a high confidence and reliability that the medical device being manufactured will not fail the specifications when on the market. The medical device engineer will generate a test flow that allows for the most efficient use of units, and therefore budget, that guarantees all Product Specifications are met. Depending on the class of medical device.

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