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Welcome to our Library of Regulatory, Certification Information and Updates in the Medical Device Area

Save the date! GMED North America is coming into force at #RAPS2019!

September 21-24, 2019

Booth427

The #2019RAPS Regulatory Convergence Conference is, held at: Pennsylvania Convention Center, 1101 Arch Street, Pennsylvania. PA

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November 18, 2019 | Crowne Plaza 4290 El Camino Real, Palo Alto, CA 94306

 

Calling all Medical Device enthusiasts of the (EU) Regulatory framework !!

(RA/QA professionals, Medical Device experts, manufacturers and others)

  GMED NORTH AMERICA FORUM November 18 2019 Palo Alto CA rev 2

 

We are happy to announce our annual GMED North America Forum. Come and meet us for a day of regulatory and technical updates and information. We have created an exciting and interesting program with a strong emphasis on the new (EU) Regulations on 2017/745 for Medical Devices and 2017/746 for In- Vitro Diagnostic Devices.This forum is created by our organization and is open to RA/QA professionals, Medical Device experts,and manufacturers. The forum format will feature presentations by our GMED national and international regulatory experts with facilitated workshops.

 

              Agenda

8:00-8:30

Breakfast

8:30-9:00

Opening statements

9:00-10:00

Transition to MD Regulations 2017/745 MD and 2017/746 IVD

Article 120 implementation

10:00-10:45

Manufacturer guest speaker

10:45-11:00

Break

11:00-12:00

Clinical Evaluation under MDR 2017/745 - Review and Compilation of Clinical Data

12:00-1:00

Lunch

1:00-2:00

Active MDs (including those with Software )   

What Testing in the context of the CE marking ?

2:00-3:00

Medical device Usability 

EN 62366

Focus Group

Clinical Evaluation under

MDR 2017/745

Focus Group

Person Responsible for Regulatory Compliance (PRRC)

Focus Group

3:00-4:15

Workshop

Workshop

Workshop

4:15-4:30

Break

4:30-5:15

Regulatory/Quality

Roundtable

Auditor  

Roundtable

Technical Assessor

Roundtable

 

In an effort, to mitigate, potential cybersecurity threats due to the increasing levels of interconnectedness and data exchange between medical devices— Health Canada has released a guidance document on “pre-market requirements for medical device cybersecurity.”

The guidance document defines cybersecurity as, “the body of technologies, processes, practices, responses and mitigation measures designed to protect a medical device against unauthorized access, modification, misuse, or denial-or-use, and against the unauthorized use of information stored, accessed, or transferred to or from a medical device.”

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On June 6th, 2019 the European Union released a document, with a note from the Irish and German Delegations on the implementation of Regulation (EU) 2017/745 on medical devices. The document addresses the increased number of discussions regarding the challenges and concerns facing stakeholders (manufacturers, notified bodies, authorized representatives, distributors, competent authorities, European Commission) in the medical device sector to implement the new Regulations in a timely and effective manner.

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The European Union has constructed an excel document detailing essential information regarding the MDR/IVDR implementation rolling plan. The document is organized into two different sections: implementing acts and other actions/initiatives. This document is intended to coexist with the “MDR/IVDR roadmap,” which was created by the Competent Authorities for Medical Devices project (CAMD) In cooperation with the EU Commission which involves a much more detailed synopsis of all the initiatives and guidance documents expected to be undertaken during the period of transition by the Commission and the National Competent Authorities.

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The International Medical Device Regulators Forum (IMDRF) held the fifteenth meeting of the Management Committee (MC) in Moscow, Russia on March 18th -21st, 2019. The MC consisted of regulatory leaders from around the world such as: Australia, Brazil, Canada, China, the European Union (EU), Japan, Russia, Singapore, South Korea, and the USA.

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On March 13th, 2019 the Council of the European Union released two corrigenda documents, pertaining to the Regulation (EU) 2017/745 on Medical Devices and the (EU) 2017/746 on In Vitro Diagnostics Medical Devices. In an effort to rectify mistakes and discrepancies within the new European Regulatory framework, Member States were allowed to send comments and suggestions up until March 20th of this year. Then, on May 5th,2019 the official documents for the (EU) MDR 2017/745 and IVDR 2017/746 corrigenda were released by the Official Journal of the European Union.

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    The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope of EMA’s activities and should be read in alignment with the new Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on In Vitro Diagnostic medical devices.

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       A recent survey was conducted by Team-NB to determine how notified bodies were approaching the application process for designation under the new EU IVDR 2017/746. The survey report was closed on January 11th, 2019 and reveals that a total of 35 notified bodies responded, twenty of those were members of Team NB and fifteen were not (non-members NB).

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November 26th , 2017 saw Notified Bodies able to engage with their designated Competent Authority (CA) to apply for a notification status under the EU MD (2017/745) and/or IVD (2017/746) regulations.

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