Our Services
Quality with Value Ltd., is an Israeli based QA/RA Services company, established in 2017.
It provides various services for the Medical Devices industry.
A one-stop-shop that provides all services under one roof, supporting all types of companies.
Our vast experience, affordable services and partnerships provide the industry the best solution for your QMS and Regulatory challenges.
Management System
Quality with Value Ltd. provide expertise with the implementation of various Medical Devices industry management systems, e.g. - BS/EN/ISO13485, 21CR820, EU 2017/745 MDR, EU 2017/746 IVDR, MDSAP and more.
Experienced with leading companies through Notified Bodies and FDA audits.
QWV’s provides trainings in various aspect of the Medical Devices industry: Design and Development concepts, Corrective and Preventive Actions, Sampling Methods, Production Process Validation, and more.
Production Lines
Quality with Value Ltd., specializes with the challenges presented by various industries from low-tech to multi-disciplinary products.
QWV provides quality solutions for active and no-active devices, implants, dispensable products and more.
QWV shall support the establishment and the maintenance of your product’s unique production technology to comply with regulatory requirements enabling the top-notch quality.
Production Process Validation
Establish and execute Production Process Validation protocols at your production lines (in-house or outsourced) – ensuring your product is provided to end-user with highest quality.
QMS Audits
QWV provides affordable and quick solutions for Internal Quality Management Audits, along with Suppliers audits – tailored for your company’s needs.
Vast experience in ISO1345, 21CFR820, EU 2017/745 and MDSAP audits.
QWV’s personnel supports the Israeli Institute of Standards (“Machon HaTekanim”) for ISO13485 Audits.
Regulatory Submissions
Quality with Value Ltd. comes along with on-hand abilities and capabilities to support your challenges with regulatory compliance.
Experienced with FDA 510(k) Submissions, EU MDD and MDR Submissions and Israeli AMAR.