by mtvgr | Dec 16, 2020 | News
MDR introduction on May 26, 2021 – is your company prepared? MDR is coming on May 26, 2021. For Swiss Medtech Companies this also means a decision whether or not to prepare for a set-up with an European Representative (EAR) or not. Swiss Medtech has issued...
by mtvgr | Aug 21, 2020 | News
Virtual Audits in Medtech – a Call for Action In a recent Webinar, the role of virtual audits was assessed. Virtual or remote audits are currently one of the most relevant topics within the Medical Device Industry, especially in times of the corona pandemic...
by mtvgr | Apr 18, 2020 | Information
Checklist for a Secure Remote Audit Recommended measures for your video conferencing system Use a registered account (not a free service) Make sure of latest software version Protect all meetings with a password Chose a service with a “waiting room” option, check-in...
by mtvgr | Apr 17, 2020 | News
MDR introduction postponed to May 26, 2021 (Swiss Medtech) On 17 April 2020, the EU Parliament adopted a proposal to postpone the date of application of the Medical Devices Regulation (MDR) by one year to the 26 May 2021. The regulation shall enter into force on the...
by mtvgr | Apr 14, 2020 | News
Remote Audits allowed by EU Commission See MDCG guidance how notified bodies can run audits while quarantine / travel restrictions prohibit site visits. The document clearly points out to use “the most advanced available Information and Communication...
by mtvgr | Apr 3, 2020 | Information, Information
Remote Audits for Medical Device Manufacturers: protect your sensitive Data & Trade Secrets! Medical device manufacturers must grant access of highly sensitive data and information to Notified Bodies during Remote Audits. Although such information is never meant...
