Quality Validation & GxP in Medical Device2020-09-15T19:12:55+00:00

Quality Validation & GxP in the Medical Device filed

Medical Devices are being used to treat, diagnose, and cure, and as a result, pose a high risk to patients. This is the main reason why the medical device industry is characterized by stringent levels of supervision and regulation. The main target of the Quality Management System, SOPs training, verification and validations, is to maintain public health while minimizing the chance and risk of harm to human life

The field of quality system management as reflected in ISO 13485, ISO 27001, ISO 27799, GDPR, MHRA and HIPAA requirements that effectively govern all processes involved in the development, production and accessibility of medical device to end customer and physicians.
Health authorities’ quality requirements and guidelines in the medical device industry are constantly updated to provide patients and doctors with reliable, accurate, sensitive, high-quality, safe and reliable medical devices. Part of the certification process includes validation and validation (V&V).
Proper verification/certification / validation, alongside an effective and functioning quality management system, will improve the reliability, accuracy and performance of the medical device, and its quality and ensure that the product successfully meets both user expectations and requirements dictated by health and regulatory authorities throughout its life cycle.

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Quality Validation & GxP consulting services in the medical device filed

  • Quality Management System

  • ISO 13485 certification

  • Medical device design control

  • Risk analysis and risk assessment based on ISO 14971

  • DMR- Device Maser Record

  • Design History File

  • Compliance with FDA, ISO, CE, GxP  regulations

  • Technical file

  • Quality system training and courses

  • Risk Assessments and risk analysis training

  • Cleaning and sterilization validation

  • ISO 27001, ISO 27799 and ISO 14001 certification

  • Pre-audit, gap analysis & training towards FDA/NB inspection

  • Preparation for FDA, CE, ISO quality tests and reviews
  • Manufacturing and assembly process controls

  • Validation & Verification (V&V)

  • Software & ERP system  21CFR part 11 & Annex 11 validation

  • Validation for medical cellular applications

  • Validation for cleaning and manufacturing processes

  • Cleaning & disinfection for Multi-use Medical Device

  • Validation and quality improvement project management

  • Validation for sterilization and sterilization
  • Validation for clean rooms
  • Validation for packing and transporting based on ASTM D4169, ISO 11607, ASTMD 7368

  • Validation training and courses

  • Bio-compatibility materials

  • CE marking, MDD, MDR

  • Suppliers and contractors quality inspections and audits

  • Policies and procedures writing and training

Other medical device services

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