NEW – The Qmed Academy Book Club

Important new MDCG guidelines are released from the European Commission. These are importance guidance documents for all of us working within developing and selling medical devices... [Read more]

May 19, 2020 / Helene Quie, CEO at Qmed Consulting A/S

MDCG Guidance

The pandemic COVID-19 has resulted in various restrictions to countries around the globe. It has affected the ability of notified bodies to conduct mandatory on-site audits under the medical device legislation. The World Health Organization has published guidance on temporary extraordinary measures, which are related to medical devices, Notified Body audits during times of COVID-19. It allows continued availability of safe medical devices to the market and... [Read more]

May 13, 2020 / Helene Quie, CEO at Qmed Consulting A/S

How to Spend the Time

Several guidance’s, posts, webinars have been published addressing what evidence collection due to the COVID-19 pandemic, and with this Newsletter we are publishing where to find the different national guidelines and recommendations. Additionally, the MDR Amendment allow us to reconsider our strategies and potential scenarios. In this article... [Read more]

May 13, 2020 / Helene Quie, CEO at Qmed Consulting A/S

Sum up of the new MDR amendment from The European Parliament

While we are waiting for the MDR amendment to be discussed and agreed upon by the European Parliament and the Council hopefully before end May through an accelerated co-decision procedure lets try and sum up what it could mean for manufacturers of medical devices (note: As for the In Vitro Diagnostics Regulation (IVDR), which will be applicable from 26 May... [Read more]

April 8, 2020 / Helene Quie, CEO at Qmed Consulting A/S

Covid-19: Letter from Qmed management

As the impact of COVID-19 intensifies globally, governments and healthcare systems come under extraordinary pressure. And healthcare professionals are holding the front line to save lives... [Read more]

April 8, 2020 / Helene Quie, CEO at Qmed Consulting A/S

The revision of ISO 14155 is available

The final draft of the new third edition of the ISO 14155 is being prepared for circulation. This means that at the present stage, only editorial changes are permitted, and therefore this draft version can be used by sponsors designing clinical investigations of medical devices... [Read more]

October 10, 2019 / Helene Quie, CEO at Qmed Consulting A/S

As healthcare professional or institute - what does the new medical device regulation change for you?

The publication of the MDR in May 2017 marked the start of a 3 year period of transition from the MDD and the AIMDD. During the transition period the Regulations will come into force gradually, starting with provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the Regulations... [Read more]

September 9, 2019 / Helene Quie, CEO at Qmed Consulting A/S

How to determine what Post Market Clinical Follow-up activities to initiate?

With the Medical Device Regulation coming fully into force on 26 May 2020, there is a risk that a majority of the medical devices on the European market converting from the Medical Device Directive into the new Regulation will be considered by the Authorities and Notified Bodies to have insufficient clinical evidence to support their continued... [Read more]

July 24, 2019 / Helene Quie, CEO at Qmed Consulting A/S

Case Story - Investigator Initiated Studies

An organisation may fund research without being the Clinical Sponsor. A Clinical Sponsor is the responsible party for a study or investigation and is per definition defines as... [Read more]

June 22, 2019 / Helene Quie, CEO at Qmed Consulting A/S

Are you our new CRA?

Do you have a solid clinical research background? Do you want to drive clinical trials in a company that ensures reliable and thorough approvals for new medical devices? As our new clinical research associate (CRA), you will embark on an exciting and collaborative career... [Read more]

June 7, 2019 / Helene Quie, CEO at Qmed Consulting A/S

The new Medical Device Regulation – and its impact on innovation

Last week the European commission published the new Medical Device Regulation (MDR) and the question on how this will impact the Medical Device industry within Europe have been asked by many. The purpose of this new regulation is to ensure... [Read more]

May 17, 2017 / Pierre Pelletier & Anette Kristiansen, Qmed Consulting A/S

Are your investigator and site ready for an FDA inspection? - Part 2

FDA’s Compliance Program Manual provides Inspectors with instructions for evaluating industry compliance with regulations and Good Clinical Practice (GCP). Among other activities, the FDA Bioresearch Monitoring (BIMO) Program involves site visits to clinical investigators, sponsors, monitors, contract research organizations, nonclinical (animal) laboratories, and... [Read more]

March 31, 2017 / Anette Kristiansen, Senior Advisor at Qmed Consulting A/S

Are your sites prepared for FDA inspection of your clinical investigations in EU?

FDA’s Compliance Program Manual provides Inspectors with instructions for evaluating industry compliance with regulations and Good Clinical Practice (GCP). Among other activities, the FDA Bioresearch Monitoring (BIMO) Program involves site visits to clinical investigators, sponsors, monitors, contract research organizations... [Read more]

March 26, 2017 / Helene Quie, CEO at Qmed Consulting A/S

MEDDEV 2.7/1 Rev 4 Clinical Evaluation: Are you ready to update your clinical evaluation report.

A new version of the European Guideline MEDDEV 2.7/1 rev 4 was issued in June 2016 affecting all companies that market medical devices in Europe. This guidance promotes a common approach to clinical evaluation for medical devices regulated by the directives 93/42/EEC... [Read more]

March 14, 2017 / Helene Quie, CEO at Qmed Consulting A/S

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