Latest industry news and developments
EU Reference Laboratories according to the IVDR should be enabled to verify by laboratory testing the performance presented by the manufacturer and the compliance of devices of highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance. Following […]
In January 2024, a new MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template was created to standardize the way medical incidents, serious incidents and reporting trends are reported. It is the responsibility of medical device and in vitro diagnostic medical device manufacturers to monitor adverse events, evaluate them and report them to the relevant competent […]
During the prestigious event in Hungary, our representatives gave lectures (“Clinical trials of innovative medical devices – challenges and regulatory consequences” by Katarzyna Wesołowska) and participated in very interesting debates (discussion panel with the participation of representatives of notified bodies and our Adam Sobantka entitled “MDR/IVDR trasition strategies and opportunities”), and in the meantime they […]
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 […]
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 […]
