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The EU MDCG 2019-7 provides guidance on "Persons Responsible for Regulatory Compliance’ (PRRC). The European Commission (EC) has published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will challenge SMEs and start-ups, but ...
This 206-page instruction manual is free with our ISO 45001 Lead Implementer Course. It is not for sale. But it is everything you'll need to develop, implement, and maintain a management system to ISO 45001 standard.
Did you know that cybersecurity is addressed under ISO 13485:2016 Clause 7.3 requirements? The Royal Academy of Engineering (RAE UK) report ‘Cyber Safety and Resilience’ (March 2018) suggests that the healthcare sector can learn from other industries when it comes to guarding against ransomware attacks, data breaches and hacking of connected health devices. That was just the beginning. Since then ...
This 100+ page 'instruction manual' is available free with our ISO 27001 Lead Implementer Course. It is not for sale. But it is everything you'll need to develop, implement and maintain a management system to ISO 27001 Certification standard.
deGRANDSON Global holds ISO 21001 Certification because it's the only one that matters as, without independent auditing to confirm compliance, it's only a badge. We started by asking what would be the best choice for Lead Auditors, Consultants, and others wishing to audit, implement, or maintain ISO Management Systems to a high standard.
deGRANDSON offers world-class tuition, internationally-recognized certification, and budget-friendly pricing. Here are some of the features of our Courses...
deGRANDSON offers world-class tuition, internationally-recognized certification, and budget-friendly pricing. Here are some of the features of our Courses...
Patient data security concerns have led to a big increase in a number of Medical Device manufacturers adding ISO 27001 to their certification Patient Safety Risk Assessment has shown manufacturers that there are significant risks not being controlled that an ISO 27001-compliant information security management system (ISMS) can resolve.