About me

My values

Do the right thing when no one is looking

My Core Competencies

  • ISO 10933,

  • ISO 11607

  • ISO 11137,

  • ISO 11737l,

  • ISO 13485,

  • ISO 14971,

  • ISO 14644,

  • ISO 15223,

  • ISO 17655,

  • ISO 20417,

  • ISO 62304

  • Competency with CE Marking to the Medical Device Regulation (2017/745) & In Vitro Diagnostic Regulation (2017/746) and UKCA (UK MDR 2002).

  • Lean Six Sigma Black Belt

  • Regulatory submissions

  • Liaisng with notified bodies

  • Technical file creation, management and review

EU MDR & IVDR certification

  • Quality Management System creation following ISO 13485:2016

  • FDA 510k, PMA, 21 CFR part 820, 21 CFR part 11

  • Risk management following ISO 14971:2019

  • Usability following IEC 62366

  • Software Lifecycle management following IEC 62304

  • Training of your personal

  • Realization of your audit activities (Internal, Supplier, Due Diligence)

  • Technical Writing (Clinical Evaluation, Performance Evaluation, PMCF)

  • Backoffice staff for your company

  • SaMD development support

  • Registration in different countries (USA, India, Brazil, Mexico, South

  • East Asia, Middle East, Africa)

  • PMS activities

  • Labelling and IFU creation and review

  • Review of your documentation prior submission

  • UK-EU-Swiss Authorized Representative

  • Employee Coaching

  • PRRC