EU Data Protection Regulation

This regulation applies to all companies collecting and processing personal data in the EU and does include medical devices.  There is NO grandfathering under the GDPR, so in May 2018 all existing systems must be able to meet these requirements.   It specifically lists genetic data and biometric data as sensitive personal data.  Developers (both medical device and health products that are not regulated as medical devices that collect or process personal data) will be under specific obligations to introduce data protection by design and default into their systems.

scpred_standardsnavigator_EU_Data_Protection_Regulation

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

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Partners located in the US (CA, FL, MA, MN) and Italy.