RandiHauerberg_RegulatoryAffairsEditor-in-chief, Senior Partner
Randi Hauerberg
Principal Advisor/Team Lead,
Regulatory Affairs & Quality Management
Direct (+45) 22 47 01 55
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Randi Hauerberg has more than 25 years’ experience within Regulatory Affairs & Quality Management, having submitted and obtained worldwide approval of numerous products within medical devices, in vitro diagnostics and combination products such as CE labeling according to MDD 93/42/EC, IVDD 98/79/EC, FDA 510(k) clearances and PMA approvals, Health Canada, CFDA, PMDA, KFDA, Brazil, Mexico, and Russia etc. Randi also helps MedTech companies by establishing MDR Roadmaps in relation to the MDR/IVDR.

Her many years of experience within Regulatory Affairs from manufacturers of medical devices, in vitro diagnostics and combination products combined with direct responsibility towards the authorities, contributes to her extensive knowledge about regulatory requirements worldwide in combination with obtaining regulatory approval with a focus upon speed to market and turnkey. Randi is Official Correspondent towards FDA and Health Canada and overall responsible for CE labeling.

She has previously held positions within Regulatory Affairs with Ferrosan A/S, Dako, Radiometer, PNN Medical, and BK Medical. Randi is also Chairman of the RA Expert Group outside EU, a member of the RA Expert Group within EU at Medicoindustrien. She has previously been a member of S-264 which is the Standardization Committee within IVD.

During her many years of experience she has contributed successfully to development projects, clinical, technical, marketing, sales and support, and approval of medical devices and in vitro diagnostics.

Carina Hoffmann Vargas-smallAuthor
Carina Hoffmann Vargas
Regulatory Affairs Consultant
Direct (+45) 22 47 12 52
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Carina started in the medical device industry from the get and has, through a fast learning curve in cross organizational project management, obtained great practical experience with i.e. usability, clinical evaluations, PMS, as well as the various FDA and Health Canada documentation practices. Her broad understanding of the various processes in medical device companies make her adept to see how the requirements of the regulations and guidelines are best met in a way that satisfies the involved parties.

Her knowledge extends past the below regulations and guidelines, but to just mention a few;

  • MDD 93/42/EC, MDR 2017/745, IVD 98/79/EC
  • ISO/EN 62366 Usability
  • MEDDEV 2.7.1 Guidance on clinical evaluation
  • MEDDEV 2.12.1 Guidance on post market clinical follow up
  • ISO/EN 13485 Quality management systems
  • FDA regulation [CFR part 820] Medical device quality system regulation
  • ISO 14971 Risk Management

Her knowledge has been built through the past years of;

  • Project Management
  • Medical Device Classification (IVD/MDD/MDR)
  • Mapping of Regulatory strategy/pathways
  • Multiple clinical evaluations for MD and IVD and clinical utility, and various other CE, FDA, Health Canada and CFDA testing and documentation
  • Management of market feedback database(s) and other PMS activities, data analysis and procedure writing
  • Multiple NB audits, annual surveillance, Technical Files and re-certifications (ranging from class I to III) and managing of non-conformities / observations through pragmatic work and various rationales, avoiding costly further testing
  • Risk management work
  • Usability studies; planning, testing and reporting including usability related to user interfaces of unknown provenance (UOUP)

She is member of the expert groups for Clinical Evaluations and Trials as well as the expert group for Post Market Surveillance at Medicoindustrien, a medical device industry association for companies in Denmark, and her natural curiosity and hunger for knowledge keep her at the forefront of the stir in the medical device industry, and having partaken also in transition processes from the European Medical Device Directive to the new Regulation she is one step ahead, and her foundation is solid with various courses in i.a EN ISO 13485, EN ISO 14971, EN 62366, and PMS under the new Regulation.

Knud Lykke Jensen-smallAuthor
Knud Lykke Jensen
Senior Consultant, Quality Assurance & Regulatory Affairs
Direct (+45) 22 47 86 12
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Knud has more than 20 years hands on experience within QA Management, Regulatory Affairs and medical devices. He is a certified lead auditor, has developed and maintained quality systems according to ISO/EN 13485, and obtained multiple approvals of medical devices, both within EU, USFDA but also internationally. He is skilled in performing GAP analysis, internal and external audits, developing SOPs, performing change control and CAPAs.

He has previously held positions with Price Invena within QA/RA, but also worked within the dental industry as QA responsible person.