The Benefits of Achieving ISO 13485 Certification for Your Medical Device Business in the UK
Introduction ISO 13485 certification is a crucial step for any medical device business in the UK. It indicates compliance with international standards for quality management systems (QMS) tailored to the medical device sector, ensuring consistent adherence to customer and regulatory demands. This certification offers...
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Understanding CE Marking CE stands for Conformité Européenne, which translates from French to "European Conformity". It's a marking that signifies a product's compliance with various safety, health, and environmental protection standards set...
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What is CE Marking? CE stands for "Conformité Européenne," which is the French term for European conformance. Here is complete guide to CE marking process. All 27 EU members, as well as...
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(PMS) Post-Market Surveillance for medical devices is a regulatory requirement. It is mandatory in global markets including the United States and European Union. PMS comprises of activities that relies on data gathering....
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After separating itself from the European Union, Great Britain introduced UKCA Mark mandatory for medical devices to conform to the new regulations. Any manufacturer who wishes to enter into the UK market...
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Any manufacturer who intends to market their medical devices, including in-vitro diagnostics in the UK, must register medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) before placing them into...
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European Union Medical Device RegulationIntroduction European Union Medical Devices Regulation (EU MDR)Reasons for replacing Medical Device Directives (MDD)Medical Device ClassificationScope of EU MDRChallenges in implementing the MDREU MDR ComplianceReference Introduction European Union...