Yuval Shapiro, B.Sc., M.Sc., MBA

Medical Devices | Telecom | Production | EMS


Management Systems according to ISO13485: 2016, EU - MDD/MDR, 21CFR820, ISO9001: 2015, ISO27001, ISO14001 & ISO45001: 2018 (OHSAS18001)

  • Establishment and implementation of QA, Regulatory, Environmental and Safety programs

  • Documentation of work processes in procedures and work instructions

  • Organizational measurements - KPI

  • Internal quality audits

  • Preparing and representing the organization toward third party quality audits

  • Risk management programs: mapping, evaluation, provision of medicines and their timing

  • Quality management surveys

  • Management of corrective and preventive actions – CAPA

  • Training


Management Systems
  • Regulations and standards - mapping the regulations and devices that the product under development is required to comply with

  • Supporting the Project Manager in its implementation - PMO

  • Development folder management (DHF)

  • Risk Management (FMEA)

  • Product verification strategy

  • DOE – Design of Experiment

  • Reliability calculations

  • Support for environmental experiments

  • Training

Design & Development Quality
  • Engineering change management

  • Documentation change management

  • Device Master Records

  • Transition from development to production: Preparation of work instructions for production and testing

  • Adverse events investigation

  • Safety tests support (IEC60601, UL, etc.)

  • Validation of production processes - Production Process Validation

  • Improving production processes 6Sigma / 5S

  • Corrective and Preventive Actions - CAPA

  • Supplier quality: evaluation, control, and handling of SCAR complaints

  • Statistical analysis

  • Training

Engineering & Production Quality


Quality Assurance & Regulatory Affairs Expert for products and companies primarily related to medical devices and telecom that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries.

More than 20 years of experience in QA; including MD&D RA & QA (EU-MDD/MDR, 510k);QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000‎; EMC & Safety Certifications
Supply Chain QA & Supplier QA; CAPA; Training; Six Sigma; Process Validation; 5S and Lean Production; Configuration Control.

Credo אֲנִי מַאֲמִין

"Quality is Free; it cost money, but it pays itself"

(P. Crosby)



Production Lines



Management System




Medical Devices

Technical Files

Regulatory Submissions


Production Lines

Internal Audits

3rd Party Preparations


Production Lines



Process Validation




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