Petros Malitas

CEO & Managing Director

PKNM Solutions Sàrl

Colombier (VD), Vaud, Switzerland

2 profile visitsBioTech

Niche Consulting Firm on Pre -Clinical Development, Clinical Development, Medical & Regulatory Affairs and Translational Applied Medicine

About

·      Design / Evaluation, / Implementation and Due Diligence of Translational Projects

·      Pre-Clinical Development / Animal Studies, Computational Studies, In Silico Verification + Validation

·      CLINICAL DEVELOPMENT Clinical Studies fir most of the major Therapeutics Clusters based on CGPs Globally

·      MEDICAL AFFAIRS Medical Evaluation and Medical "Sponsoring" / Entrance to the Market

·      REGULATORY AFFAIRS

·      ISO 9001,

·      ISO 13485:2016,

·      ISO 62304 / IEC 62304 Medical Devices Software

·      ISO/DIS 14971:2018: Application of Risk Management To Medical Devices

·      Biocompatibility; ISO 10993, USP

·      Cytotoxicity; ISO 10993-5, USP

·      Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745

·      ISO 27001 & GDPR and

·      MDD / MDR

·      IVDD / IVDR

·      CE Mark for Class I, IIa, IIb and III & FDA Clearance(s)

·       ISO/IEC 17024:2012: Personnel Certification is popular to harmonize the personnel conformity assessment process worldwide

My organisation

PKNM Solutions Sàrl

Skills

  • QA
  • Regulatory Affairs
  • Medical Affairs
  • Entrance to the Market
  • Verification & Validation
  • Safety
  • Certification
  • Audits' Support
  • Clinical development
  • Risk Analysis
  • Risk Management
  • Post Market Follow Up
  • Post Market Surveillance
  • Translational Medicine
  • testing

Interests

  • Innovation in Medical Technology
  • Medical Devices
  • IVDs
  • pharma
  • Cell & Genetic Treatments
  • biotechnology

Marketplace (1)

  • PartnershipUpdated on 20 June 2023

    QA & Regulatory Development

    Design, Evaluation, Pre -Clinical & Clinical Development, Medical & Regulatory Affairs and Translational Applied Medicine

    • Consulting
    Author

    Petros Malitas

    CEO & Managing Director at PKNM Solutions Sàrl

    Colombier (VD), Vaud, Switzerland