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User story: Risk & QMS solution that lets you sleep at night

Skinuvita is a German startup making phototherapy more accessible to patients with chronic skin diseases through e-health technologies for a safe and efficient home treatment. Skinuvita uses e-health technologies to enable a safe and efficient phototherapy treatment.

Skinuvita was looking for electronic Document and Risk Management solutions, fit for a HealthTech company, and integrated to Jira and Confluence

Here is what they recommend for the start-ups in MedTech domain to consider:

Q: Do you have any recommendations to other medical device and digital health startups in achieving regulatory compliance?

A: Indeed, three things come to mind that could help a medical device or digital health startup to achieve regulatory compliance:

  1. Start as early as possible with the implementation of the QMS system and the technical documentation.
  2. Get familiar with the international standards – in addition to ISO13485, ISO14971, IEC62304 and IEC60601, check also the IEEE standard for software documentation before your development work.
  3. Most companies do the QMS retrospectively so having software documentation from the beginning will help you write the technical documentation for your QMS as well. Find a solution that fits your company’s workflows so you don’t need to change your processes because of the tool.

Read here the full article about what are the must-haves for a compliant electronic QMS and how Skinuvita gained some peace of mind through implementing SoftComply eQMS solution on Atlassian Confluence.  



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