CE Mark – IVDR
In Vitro Diagnostics and the IVDR HomePagesWhat are In Vitro Diagnostics?In Vitro Diagnostics (IVDs) are devices and accessories that perform tests on specimens derived from the human body such as…
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Sterilization Validation
Sterilization Validation HomePagesEO sterilization validationMedical device sterilization validation is one of the most important elements of medical device Validation & Verification plan, since compromised state of sterility of medical device…
Become PRRC
Person Responsible for Regulatory Compliance (PRRC) HomePagesEnsure EU regulatory compliance through the Person Responsible for Regulatory Compliance (PRRC)The Person Responsible for Regulatory Compliance (PRRC) is a new requirement of the…
Integrate QA & Development
Integrate QA & Development HomePagesWhy should Quality Assurance (QA) and development be integrated?The fierce and intense cut-throat market requires companies to release their products to the market as quickly as…
HIPAA
HIPAA HomePagesHIPAA complianceThe Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 by the US government to protect personal healthcare data from leaking out of the healthcare and…
IEC 62304
IEC 62304 HomePagesIEC 62304 complianceThe IEC 62304 is an international standard outlining product life cycle processes pertaining to the development of software used with medical devices. It was developed by…
Strategize Regulation
Strategize Regulation HomePagesWhy do I need a regulatory strategy?Speed to market is important to your return on investment (ROI), particularly when trying to introduce an innovative medical product. The quicker…
ISO 27001
ISO 27001 HomePagesWhat is ISO 27001?ISO/IEC 27001:2013 (or ISO 27001) is an international standard that provides a foundation for establishing an information security management system (ISMS) in organizations. Its goal…
CE – MDR
CE-MDR HomePagesWhat is Regulation EU 2017/745 on medical devices (MDR)?Published in May 2017, the MDR is formally the definitive regulation governing the marketing of medical devices within the European Economic…
FDA – 21 CFR Part 820
FDA – 21 CFR Part 820 HomePagesWhat is 21 CFR Part 820?21 CFR Part 820 is FDA’s Quality System Regulation (QSR) on how to manage a Medical Device’s Quality Management…