ISO 13485 and the High Level Structure (HLS)


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I've just wrote some a text explaining the problem of ISO 13485 na Ethernet High Level Structure (HLS) for mansamente standards. As several people have asked me this, I think It would be interesting to share (please note that these are my thought on the matter, not the thoughts of any group I participate):

- The medical devices area is highly regulated. This means that regulatory requirements (which, differing from standards, are mandatory) are specifically laid out and required for devices to be put into market (and sometimes, even manufacturer. For example, in Brazil, product registrations enable both manufacturing and putting into the market).

- One the the pillars of the medical devices regulations, in general, is the need for the manufacturer manufacture, in a controlled and repetitive way, the devices designed (a risk management process, together with other related process used during design, used during design guarantees safety). The way for manufacturer to guarantee this controlled and repetitive manufacture system is to have a QMS, so a QMS is required by most regulations.

- Right now we have mainly two different approaches to QMS requirements for medical devices - GMP (good manufacturing practices) and a more general QMS requirements. QMP requirements, which are written into the regulations (such as in the EUA and Brazil) are based on older versions of ISO 9001/ISO 13485 (the 1994/1996 versions). General QMS requirements are either explicitly stated in general ways in regulations (such as the MDD/MDR which details requirements into the CE Marking routes) or used by requirement a standard such as ISO 13485 (Canada, for example).

- It's important to understand the changing regulations are not easy nor desirable (because both regulators, industry and patients are used to that regulation that historically results on safe and effective devices). Medical device regulations ARE updated (such as the proposed MDR in Europe), but they do keep what is working
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