Mark Sikorski
Sales Director IFUcare
Shared Services — QbD Group
Mark leads sales for IFUcare within QbD Group's Shared Services division. He works closely with medical device and IVD manufacturers to align eIFU strategy with EU MDR, IVDR and EUDAMED requirements, helping teams meet upcoming registration deadlines with confidence.
Connect on LinkedInArticles by Mark
Human Factors and Usability: The Part of eIFU Compliance Teams Still Underestimate
Discover why usability engineering and human factors are now essential to eIFU compliance, and how IEC 62366-1 supports safer digital instructions for use.
Beyond the QR Code: Where Digital Labeling Is Actually Heading
Discover how eIFU is evolving beyond QR codes through UDI, EUDAMED, GS1 Digital Link, NFC, and connected digital labeling ecosystems.
Why Early-Stage MedTech Companies Should Decide on eIFU Before Their First Submission
Discover why early-stage MedTech companies should make eIFU part of their regulatory strategy before their first submission to avoid costly redesigns and delays.
IFU packaging best practices: the environmental case for eIFU
Discover how eIFU helps MedTech and IVD manufacturers reduce packaging waste, support PPWR compliance, and strengthen sustainability credentials.
Where eIFU Is Heading for IVDs: What Manufacturers Should Watch Next
Discover the current eIFU rules for IVDs, the near-patient testing exception, and the regulatory developments manufacturers should monitor next.
Your eIFU Link and EUDAMED: What the 28 November 2026 Deadline Means for Your Device Registrations
With EUDAMED registration deadlines approaching, manufacturers must ensure their eIFU links are stable, accurate, and aligned with UDI device registration requirements.