Latest industry news and developments
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 […]
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) […]
“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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Delays in medical device certification in Europe are negatively affecting innovative healthtech and biotech start-ups. There are even opinions that the Medical Device Regulations could lead to an impasse as companies wait for old and new devices to be certified under the new regulations. The confusion is caused by the Medical Device Regulation, which went […]
