Qmed News

The development and manufacture of medical devices require stringent design control processes to ensure their safety, effectiveness, and compliance with regulatory standards. This white paper provides an in-depth examination of medical design control processes, with a particular focus on the International Organization for Standardization (ISO) 13485 standard, other relevant standards and the Medical Device Regulation (MDR). The paper discusses key concepts, stages, and activities involved in design control, along with the regulatory requirements imposed by the standards and the MDR. By adhering to these standards, medical device manufacturers can streamline their design processes and enhance patient safety and product quality.

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...

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...

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...

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...

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...

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...

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...

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...

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...

Our newest article is a result of an interview by Helene Quie to Bassil Akra, AKRA TEAM's CEO, on the subject of Clinical Evaluations.

Our newest article is a result of an interview by Helene Quie to Søren Underbjerg, Qmed Consulting's Team Lead for Clinical Development and Market Access, on "The Use Scientific Surveys as a Method to Collect Medical Device Clinical Evidence".

The transition period for the United Kingdom to leave the European Union is coming to an end on 31 December 2020. After the deadline UK will be considered a third country if no...

In Switzerland, just as elsewhere, ‘Europe’ and immigration are closely connected topics. The right wing political party is very vocal in its campaigning to reduce the numbers o...

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...

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 unde...

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...

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...

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...