Accelerating Innovation & Streamlining Compliance for Medical Devices Engineering

QAdvis is pleased to participate in an exclusive webinar designed for the Medical Device Engineering Industry on the 11th of November at 10am CET. Robert Ginsberg, QAdvis Co-Founder and COB will be one of the speakers at this webinar.

 

As the medical device industry becomes increasingly competitive, systems and software delivery are emerging as key value differentiators. The rigorous regulations mandated for medical devices and the inherent difficulties of system and software implementation make product development a complex challenge.

 

In light of these challenges, IBM in association with Nohau, MicroGenesis and QAdvis have teamed up to host a live webinar titled Accelerating Innovation and Streamlining Compliance for Medical Device Engineering. In the webinar we will discuss how Engineering Lifecycle Management solutions can accelerate the development of innovative and smart products while ensuring quality control and compliance with medical industry regulations. The webinar will focus on three strategic themes: Improve Quality, Reduce Cost of Compliance and Reduce Time to Innovation.

The webinar will take a closer look at:

  • Current trends and challenges in medical device development
  • The latest technology that makes it possible to deliver quality medical devices faster
  • Best practices and advise from industry experts

 

Secure your place to this exclusive webinar by submitting the registration form here…

 

Person Responsible for Regulatory Compliance (PRRC)

One important new requirement in both MDR and IVDR is to have an assigned and dedicated Person Responsible for Regulatory Compliance (PRRC). The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by ensuring that the technical documentation and declaration of conformity is drawn up and kept up to date, fulfilling the obligations related to post market surveillance as well as reporting and investigating vigilance issues. It is also required that the PRRC controls the conformity of devices before they are released.

All manufacturer irrespective of classification, must have this person identified to fulfill the requirements and placing devices on the market under MDR and IVDR.

QAdvis can help you with understanding the requirements in your company as well as taking the role as PRRC in micro and small companies.
We can support you with defining the role as well as training and understanding of the full range of responsibilities. Learn more about PRRC here.

 

News in medical technology

The new legislation on medical devices in the EU, MDR and IVDR has greatly influenced the need for the renewal of medical device standards. This need has led to the development of completely new standards, and previous releases have been revised, to reflect the new law (MDR and IVDR) and developments on the international market. Things that are highlighted and have been included is information from manufacturers, new symbols, follow-up of products already released on the market (Post Market Surveillance) and updated risk management process.

QAdvis consultants Anneli Wiedenkeller and Cristina Albu Barkman has been involved in the renewal of medical device standards and are participating on webinars organized by SIS. All three webinars are held in Swedish.

Take the opportunity to update yourself in the field of medical device standards, listen to QAdvis Senior Quality and Regulatory Consultants, Anneli Wiedenkeller and Cristina Albu Barkman!