Where to start: CE Mark for Medical Devices
When doing business in Europe it is the manufacturer’s responsibility to carry out the conformity assessment with the European standards for its range of products. Since the introduction of the MDR (European Medical Device Regulation 2017/745) and the IVDR (European in Vitro Diagnostic Medical Device Regulation 2017/746 (EU-IVDR), we understand this process for medical devices and diagnostic products has far become more complex.
This is the reason , we have invited BSI Business Development manager, who has been an auditor himself, Arjun Joshi to share his experience in taking Australian and NZ through this process.
Your host for this session, Christelle Damiens will interview Arjun in this 20-minute Exportia LAB and the audience will have the opportunity to ask questions!
BE AWARE this session will not be recorded.
Managing Director @Exportia
Christelle Damiens is the Managing Director of Exportia, which provides an outsourced European Sales & Marketing team to non-EU B2B manufacturing and technology companies. She is also an award winning author and a business speaker. Her second book “The four steps to generate your first million euros in sales’ won the Australian Business Book Award 2020 in the Communications and Sales category and was a finalist in the Entrepreneurship & Small Business Category, as well as an Amazon best seller. www.exportia.com.au
To learn more, visit : christelledamiens.com
Senior Business Development Manager- ANZ at BSI Group
Arjun Joshi is a Senior BDM at BSI Group, an EU based notified body designated by EU Commission for CE Marking (Conformity Assessment) and various regulatory certifications for placing medical devices in various markets i.e. global market access, Arjun understands the requirements of ISO 13485 and regulatory approvals process MDR, IVDR, MDSAP, UKCA, Article 117. Arjun also has a degree in Mechanical Engineering and an MBA and has held Operations Manager roles in companies previously. Additionally, Arjun has been working in Medical devices industry for over 12 years where he has been a Lead Auditor for various standards such as Quality, OH&S, Environmental, SMETA (Ethical standard against modern slavery), etc.