News

February 1, 2024

The US FDA published its final rule aligning U.S. quality regulations (QMSR) to international standards (ISO 13485)

The US FDA has released the awaited final decree on Quality Management System Regulation (QMSR), bringing its stipulations into alignment with the widely acknowledged ISO standard. The stakeholders in the industry have until February 2, 2026 to comply with these rules. It is very important note for the manufacturers willing to start with their devices […]

January 19, 2024

What challenges will the medtech industry face in 2024?

Innovations and Development: Medical products typically have a lifecycle of only 18–24 months before a new and improved product emerges. This is just one indicator that the medtech sector is rapidly evolving, so much so that regulations struggle to keep up with progress. Most importantly is that with our help, upcoming changes will become more […]

December 22, 2023

A year in our industry and our company

We’ve had a very interesting and intense year in our industry, so it’s time for a little summary! Here’s what’s worth remembering from the vast calendar of 2023: III.2023 – Changes of transitional periods (MDR/IVDR) and removal of the “sell off” periods V.2023 – Advertisement rules for medical devices (PL) VI.2023 – Distributors database (PL) […]

December 7, 2023

AI and the future of medicine at the MedStar Innovators conference

“When possibility meets reality” – this quote accompanying one of the presentations perfectly captures the essence of today’s MedStar Innovators conference “AI and the future of medicine”, organized in cooperation with Google. Today, they met in one place, among others: healthcare industry leaders and representatives of startups with innovative technologies. – Representatives of offices from […]

December 5, 2023

Medical Research Agency conference

Our representatives – Katarzyna Wesołowska and Adam Sobantka – took part in the Medical Research Agency conference. This renowned state institution will celebrate its 5th anniversary next year and plans to be intensively involved in the development of Clinical Research Support Centers in the near future. ABM’s new project will also include moderating discussions, research […]

November 14, 2023

MEDICA – Leading International Trade Fair in Düsseldorf

This year’s MEDICA – Leading International Trade Fair in Düsseldorf attracted medical technology experts, manufacturers and suppliers from around the world. You can meet representatives from more than 70 countries. The fair is divided into thematic areas and presents a wide range of products and services for modern healthcare in doctors’ offices and clinics: from […]

October 11, 2023

We have partnered with Medical Device Network

We are very pleased to announce that we have partnered with Medical Device Network, a leading portal dedicated to news in the medical device industry. Our experts will regularly publish their articles. We encourage you to read the publication of President of the Board MDR Regulator Katarzyna Wesolowska and Clinical Trial Manager | MD Pure […]

October 6, 2023

The medical sector in 2023: description of the market, major opportunities in Poland and regulatory aspects

September 26 this year Katarzyna Wesolowska, President of MDR Regulator, co-hosted a webinar organized by SNITEM (French medical devices association) in cooperation with Valians International entitled: “Medical sector in 2023: Market description, main opportunities in Poland and regulatory aspects”. The meeting was attended by more than 130 representatives of companies from France. – We see […]

September 1, 2023

Our article in the Biotechnologia.pl quarterly

As an encouragement, a small excerpt from the article: “Compared to the IVDD, the IVDR Regulation introduces stringent requirements for the collection and analysis of clinical evidence, which are more stringent the higher the device class. Regulation 2017/746 (IVDR) also requires manufacturers to prepare and submit a performance evaluation of in vitro diagnostic medical devices […]