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