Continuing the blog posts with regard to the implementation of the European #MDR (2017/745), the article by Adam Freeman and the presentation by Frank Blömer put a focus on the requirements for audits (surveillance and unannounced) and also shows the links to the #MDSAP program. https://lnkd.in/dsTbm5m
FDA publishes Guidance regarding Principles of Premarket Pathways for Combination Products FDA published a draft guidance outlining available pathways for device-led, drug-led and biologic-led combination products. It also contains an annex listing 5 examples. The draft guidance can be downloaded here: https://bit.ly/2MS34w2 #fda #combinationproducts #biosimilars #biologics #confinis
Health Canada published Draft Guidance on Software as a Medical Device A few days ago, Health Canada published a draft guidance and a draft examples document on software as a medical device (SaMD). They are intended to clarify how that type of software fits into Health Canada’s regulatory framework for medical devices and also contains exclusion criteria for software which is not considered a medical device. Draft Guidance Document: https://bit.ly/2RvbBWB Draft Examples Document: https://bit.ly/2WAwzqD #healthcanada #medicaldevices #software #guidance #confinis
Andrea Schütz Frikart joins confinis as Senior Consultant We would like to give a warm welcome to Andrea Schütz Frikart who joined #confinis as Senior Consultant earlier this year – another great addition to our team! Andrea will be based at our offices in Switzerland. Before joining confinis, Andrea held positions in design & development, regulatory affairs and #usabilityengineering / #humanfactors in the area of #medicaldevices and #combinationproducts for companies such as #RocheDiabetesCare, #medHF and #FrikartEngineering. Last but not least she was also an inspector for medical device market surveillance at #Swissmedic (Swiss Agency for Therapeutic Products). Besides acting as a consultant, she is also a passionate lecturer for professional trainings and workshops. Andrea will assist our current and future clients in the area of medicaldevices and combination products regarding compliance with applicable regulatory and normative requirements.
TGA publishes Draft Cyber Security Guidance for Consultation Only days after Health Canada, also the Australian TGA published a draft guidance document on cybersecurity. TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials.
The guidance is intended to assist industry understand and comply with their responsibilities to ensure that medical devices are cyber secure. The guidance will also contain information to assist users (including those in health care settings) with managing cyber security matters related to the use of medical devices. Link: https://bit.ly/2Qjkd25 #cybersecurity #medicaldevices #confinis
Whenever we intend to invest in a company that plans to sell medical devices or combination products we involve confinis in our due diligence process to assess the regulatory strategy, verify compliance with applicable regulations and challenge the time required to obtain marketing authorization. confinis’ expertise regarding EU and US requirements in this area is simply unrivaled and their dynamic and entrepreneurial team are a pleasure to work with.
Patrick M. Aisher
Chairman, Kinled Holding Ltd.
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