Career at QAdvis
To our offices in Lund and Stockholm we are now looking for new colleges that will work together with us and our clients as Quality & Regulatory consultant within the Medical Device and In Vitro Diagnostic medical device industry.
Welcome Noomi
We are very pleased to announce the joining of our new colleague Noomi Altgärde and extend a warm welcome to the QA&RA consultant team at QAdvis!
Noomi has a PhD in Bioscience and a long background from working with medical devices in the development phase, with a focus on quality assurance and regulatory affairs. Her curiosity and broad background within both research and product development gives an excellent platform to understanding the complexities medical device manufacturers will face, simplifying regulatory requirements and finding hands-on solutions for both manufacturers and other stakeholders.
Read about technical documentation here.
2-day course EN ISO 13485:2016
The harmonised EN ISO 13485:2016 standard can be used to show compliance with the regulations and constitutional requirements needed for companies supplying medical devices and associated services in the EU
Update of the guidance for medical device software applications (apps)
MHRA (Medicines and Healthcare Products Regulatory Agency) has published an update of the guidance for medical device software applications (apps). The guidance provides information on when software applications are considered to be medical devices and how these shall be regulated.
The guidance consists of an overall document and three appendices.
• Medical Device stand-alone software, including apps
– Appendix 1 – Symptom checkers
– Appendix 2 – Clinical Calculators
– Appendix 3 – ‘Drives or influences the use of a device’
The guidance is applicable to standalone software and apps placed on the Great Britain market. The guidance gives examples of software and apps which meet the definition of a medical device, and it outlines the requirements for UKCA-marking.
In UK, standalone software and apps that meet the definition of a medical device are required to be UKCA-marked in line with the Medical Device Regulation 2002, as amended (UK MDR 2002) in order to ensure they are safe to use and perform as intended. CE-marked devices will continue to be recognized in the Great Britain market until 30 June 2023. Please note that for Northern Ireland, different rules apply.
If you have any questions with regards to UKCA-marking of your medical device or other considerations with regards to classification of your software or regulatory requirements, don’t hesitate to send us an email at ukrp@qadvis.com
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.
