How to Keep Up With Medical Device Product Demand and Keep Quality High
May 14th, 2013 // 9:58 pm @ jmpickett
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There is more demand than ever for medical devices as our population continues to age. Manufacturers of devices find that they have to boost production and also keep fully compliant with FDA quality regulations. It is very important to keep up with demand without sacrificing quality or FDA regulatory compliance.
One smart way to do this is to have a requirements checklist that all of your manufacturers and contract partners have to meet. This helps to make sure that all medical devices get to market fast and all software and complex circuitry is working properly and is in FDA compliance.
Here’s our quality checklist for medical devices:
- Do all manufacturing partners know the risk classification system that determines the regulatory scheme for each device? Every device in the US will be classified as Class I, II or III. Class I products are low risk and do not have any performance standards, such as exam gloves. Clsss II and III devices include infusion pumps and defibrillators. Class III devices have the most onerous controls and require a PMA to make sure they are safe and effective.
- Do all partners know FDA’s quality system regulations? All manufacturers in the supply chain have to follow specific regulations pertaining to design, tests, manufacture, packaging, labels, storage, installation and service.
- Have all partners gotten ISO 13485 certification? This helps to show FDA that a strong quality management system is functioning and will help your company get faster access to the market.
- Do all manufacturing partners understand all design controls? This is a system of checks and balances that will ID any deficiencies in design input requirements and also between the designs that are proposed and production requirements. This makes it more likely that any problems can be corrected earlier in development.
- Do you know all of FDA ‘s rules for reporting any device problems or complaints? The device manufacturer should make reports of any adverse events and report them to the agency, but any service provider should also know any reporting rules as they can run into device problems during testing.
- Do all manufacturing partners have experience with many projects for many medical markets? This is key because if they do possess this experience, this can guide manufacturers through a large maze of regulatory mandates, such as what is found in the quality system regulation for FDA.
- Do the manufacturing partners have quality and regulatory systems inside the firm that integrate well with the internal capabilities of the device manufacturer? An important aspect of this type of program is to have control over product documentation, because customers will require manufacturing partners to have records of how each device was made and tested.
All medical device manufacturers need to make good choices for their manufacturing service partners. You only should work with firms that understand the FDA quality system regulations. This simple checklist can be very effective in helping to figure out which are the best manufacturing partners to have medical devices get through the FDA regulatory process fast and to market.
