Do medical device suppliers have to comply with a lot of Guideline requirements? There are no regulations that you would be subject to directly.
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Regulatory requirements will be defined in the contract (or SLA) by the ‘manufacturer’. Suppliers to manufacturers (including distributors) do NOT require CE Marks.Īgain, no. Only ‘manufacturers’ need to engage in the protracted and (usually) expensive process for getting a CE Mark for a medical device or an IVDMD. Regulations under ISO standards define the ‘manufacturer’ as the entity that holds the marketing authorisation/licence. While you may be asked by a customer to affix a CE mark to a component, you will be doing so on the ‘manufacturer’s’ behalf.
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Do we have to get CE marking of components? a combined internal audit programme and a single nonconformance procedure). These are two distinctive standards requiring two management systems, albeit ones that are compatible with one another and have shared processes/procedures (e.g. All of which are no longer needed for ISO 9001 certification.Īn integrated management system is often suggested here. These include a quality manual, a documented management representative and preventive action, among other things.
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Do medical device suppliers have to comply with a lot of Guideline requirements?ħ. Do medical device suppliers have to comply with a lot of regulations?Ħ. Do we have to get CE marking of components?ĥ. Is ISO 9001 certification enough to supply medical devices?Ĥ. Are medical device suppliers obliged to have ISO 13485:2016 certification?Ģ. In this article we’ll consider nine frequently asked questions:ġ. There could be a lot of high-margin business that you're missing out on.
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logistics) to the Medical Device Sector are scared off by talk of CE Marking, Notified Bodies, regulatory inspections, unannounced/surprise audits and the like. Many organisations with the potential to supply components, packaging and other goods and services (incl.