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CONTACT

Inquiries

For any inquiries, questions or commendations, please call: +972-54-2052524 or fill out the following form

Head Office

4/16 Uri Zvi Greenberg ST

Giv'at Shmu'el 5442227, Israel 

 

shapiro@qwvalue.com

Tel: +972-54-205-2524

Fax: +972-3-532-6765

Get a quote: +972-54-205-2524

QUALITY

MANAGEMENT

& REGULATORY

 

Yuval Shapiro, B.Sc., M.Sc., MBA

Medical Devices | Telecom | Production | EMS

SERVICES

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
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ABOUT

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)

 
 

Topics

Production Lines

Transfer

Engineering

Management System

KPIs

SOPs

Reviews

Medical Devices

Technical Files

Regulatory Submissions

Audits

Production Lines

Internal Audits

3rd Party Preparations

 

Production Lines

Transfer

Engineering

Process Validation

 
 

Projects