Medical Device Regulatory Updates | CMS MedTech

Easy Guide on how to comply to MDR and ISO 13485

Free ISO 13485 FSCA Template

By cmsmedtech December 24, 2020ISO 13485

Free ISO 13485 FSCA Template You can buy the ISO 13485 standard here. Please Like our facebook page and comment here ORLike us on Google and comment here ORLike and subscribe us on youtube and comment hereANDemail us here from your work email (verifiable domain from company…

Easy Guide on how to comply to MDR and ISO 13485

Free ISO 13485 Corrective and Preventive Action Template

By cmsmedtech December 23, 2020ISO 13485

Free ISO 13485 Corrective and Preventive Action Template You can buy the ISO 13485 standard here. PleaseLike our facebook page and comment here ORLike us on Google and comment here ORLike and subscribe us on youtube and comment hereANDemail us here from your work email (verifiable…

Easy Guide on how to comply to MDR and ISO 13485

Free ISO 13485 Control of Nonconforming Product Template

By cmsmedtech December 22, 2020ISO 13485

Free ISO 13485 Control of Nonconforming Product Template You can buy the ISO 13485 standard here. PleaseLike our facebook page and comment here ORLike us on Google and comment here ORLike and subscribe us on youtube and comment hereANDemail us here from your work email (verifiable…

Easy Guide on how to comply to MDR and ISO 13485

Free ISO 13485 Adverse Event Reporting Template

By cmsmedtech December 21, 2020ISO 13485

Free ISO 13485 Adverse Event Reporting Template You can buy the ISO 13485 standard here. Please Like our facebook page and comment here ORLike us on Google and comment here ORLike and subscribe…

How to do CSDT

How to do Common Submission Dossier Template

By cmsmedtech December 16, 2020Asean, Cambodia, csdt, Indonesia, Myanmar, Philippines, Singapore, Thailand, Vietnam

How to do Common Submission Dossier Template (CSDT) (Video) This CMS MedTech tutorial provides the guidance on how to do ASEAN Medical Device Common Submission Dossier Template (CSDT) Visit cmsmedtech.com…

Medical Device registration in Indonesia

Medical Device registration in Indonesia

By cmsmedtech November 22, 2020Indonesia

https://www.youtube.com/watch?v=f22ggDfIFwE Medical Device registration in Indonesia: Requirements 1 Regulatory Approval from GHTF Countries such as 510(k) / TGA / CE etc. if applicable. FORM A 2 Medical Devices Distributor License…

eu medical device regulations

Common Specifications

By cmsmedtech November 10, 2020CE, common specifications

CS Links Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as…

Easy Guide on how to comply to MDR and ISO 13485

Free ISO 13485 Feedback and Complaint Handling Template

By cmsmedtech November 1, 2020ISO 13485

Free ISO 13485 Feedback and Complaint Handling Template You can buy the ISO 13485 standard here. Email us here to get and type "CMSfeedback" in the email message to get our free template…

Easy Guide on how to comply to MDR and ISO 13485

Free ISO 13485 Work Environment SOP Template

By cmsmedtech October 31, 2020ISO 13485

Free Template You can buy the ISO 13485 standard here. Email us here to get and type CMSworkenvironment in the email message to get our “Free ISO 13485 Work Environment SOP Template” if…

EU MDR technical documentation

How to do Biological Evaluation

By cmsmedtech October 31, 2020biological evaluation, CE, technical documentation

How to do Biological Evaluation (according to ISO 10993-1: 2009) This is how biological evaluation was performed previously: Identify device contact nature Identify contact time Performed test as indicated in…

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