The pathway from idea to commercialization and maintenance of a medical device can sometimes be unclear and complex. Based on the regulatory strategi, the product(s) intended use, type of user, were to use hit, applicable standards and regulations this gives different type of requirements and activities that a legal manufacture needs to act upon during the lifetime of the medical device(s).
QAdvis is a solution-oriented service provider for the medical device and invitro diagnostic sector. Our team can together with established partnerships and international network provide a high level of knowhow to your projects. We understand your regulatory workflow and can quickly intergrate into you business and give the support you need.
Our areas of expertise are for example;
Risk management
Risk management has become central in the life cycle of medical devices and is therefore one of the most important tools in the CE-marking process since it enables the manufacturer to identify the product …
Software and Cybersecurity
Throughout the software development lifecycle, collaboration between interdisciplinary teams, including software engineers, quality assurance professionals, regulatory experts, and clinicians, is essential …
Marketing approval for medical devices,
MD and IVD
The marketing approval process for medical devices refers to the process of gaining approval or clearance from regulatory authorities to sell and distribute the devices in various markets. This process involves …
Clinical evaluation and Performance evaluation
Clinical evidence is a critical component for medical device development, regulatory approval, and ongoing assessment of device safety and effectiveness. Manufacturers must conduct robust clinical …
Biocompatibility assessment
Biocompatibility assessment plays a crucial role in the overall design and development process. It ensures that device materials and design do not lead to adverse reactions when in contact with the human body …
Quality Management System for medical device manufacturers
The implementation of the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) have enhanced the requirements for the safety, quality, and performance of …
PMS – Post Market Surveillance
Post market surveillance is a crucial part of the medical device lifecycle and is emphasized in both EU MDR 2017/745 and IVDR 2017/746 …
Due Diligence
Stricter regulatory requirements on medical device economical operators (i.e. manufacturers, distributors, and importers) pose a major challenge to company acquisition processes …
Usability
The usability of medical devices is a crucial aspect that impacts effectiveness, safety, and overall user experience. Usability factors are closely related to risk management and must be …
Contact us for further information or if you want to learn more about how we can support you.
Stockholm Office Färögatan 33, 164 51 Kista, Sweden.
Lund Office Scheelevägen 17, 223 70 Lund, Sweden.
+46 8 621 01 05
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
