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Partner-Blog Comalatech #DWSC19: EU Software Developers, Are You Prepared for Major Regulatory Changes?

The Digital Workplace Summit by Communardo #DWSC19 will take place on November 13th in Hamburg. In the course of this conference Comalatech wrote this article as a partner blog.

This is a blog article from Comalatech as a part of our part­ner blogs for #DWSC19.

Over the past decade, one the most inno­va­tive areas of soft­ware deve­lo­p­ment has been in the field of medi­cal device. 30 years ago, medi­cal device soft­ware powered large com­plex machi­nes inside hos­pi­tals and labo­ra­to­ries, but today teams can build soft­ware that runs on tablets, pho­nes, or smart devices. However, even if you are buil­ding an app for an iPad, your soft­ware must meet the same regu­la­ti­ons as pro­grams that power MRI and EKG machi­nes. In 2020, major regu­la­tory chan­ges are going to come into effect which will signi­fi­cantly impact how teams need to design their devices and docu­ment their deve­lo­p­ment. Firms in the medi­cal indus­try can't take chan­ces with their com­pli­ance, so it's important they under­stand and prepare for these changes.

Regulatory Changes in the Medical Industry

In the EU, medi­cal devices must meet strin­gent regu­la­tory requi­re­ments in order to be cer­ti­fied with a "CE" mark. This includes requi­re­ments rela­ting to the crea­tion, sto­rage, and appr­oval of docu­men­ta­tion. In order to be released to the public, a medi­cal device's soft­ware docu­men­ta­tion must pass regu­la­tory audits to ensure it is com­plete and accurate.

In 2017 the EU announ­ced signi­fi­cant chan­ges to their regu­la­tory requi­re­ments. The European Medical Devices Directives was repla­ced by a new set of rules cal­led Medical Devices Regulation (MDR). There are two major con­se­quen­ces of the new requirements:

  1. Some medi­cal hard­ware and soft­ware pro­ducts that were pre­viously cer­ti­fied have to re-apply to pass the more rigo­rous standards
  2. Devices that were pre­viously exempt from the strin­gent rules are now included under the requirements

These two fac­tors mean that sud­denly a large num­ber of teams need to have QMS sys­tems that pass regu­la­tory audits. The EU set a dead­line of May 26th, 2020 for com­pa­nies to cer­tify their pro­ducts. This has led to a num­ber of teams sear­ching for new docu­men­ta­tion sys­tems that can meet their needs, and it has also crea­ted a back­log with audit bodies.

What Must Developers Do?

The first step for deve­lo­pers is to find out whe­ther your soft­ware requi­res a QMS audit. The new MDR regu­la­ti­ons clas­sify pro­ducts into three cate­go­ries; I, II, and III. Although Class I device deve­lo­pers must have a QMS, they will not be audi­ted by a Notified Body; class I is con­side­red "self-certified", so their QMS does not require a for­mal audit.

If your pro­duct falls into the other cate­go­ries, II or III, then it's cri­ti­cal that you move for­ward buil­ding your docu­men­ta­tion pro­perly. You need to ensure that you are pro­vi­ding the right kind of docu­men­ta­tion, that it is being stored cor­rectly, and that it has been appro­ved by the right peo­ple. This blog pro­vi­des a step-by-step over­view of the com­pli­ance process.

The pro­cess may seem daun­ting, but there is help available. Documentation sys­tems like Atlassian Confluence can form the back­bone for your QMS. A num­ber of teams have com­bi­ned Confluence with apps like eQMS and Comala Workflows, and seve­ral have alre­ady pas­sed their QMS audits with these apps. And, a Solution Partner like Communardo can be there to ans­wer any ques­ti­ons you might have and sup­port you on the road to regu­la­tory compliance.

More Information

Need more infor­ma­tion? There are a variety of blogs online about this topic:


2. Oktober 2019

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