Quality Management &
Regulatory Compliance
Management
Systems
About Us
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.
Our Services
Management Systems
QWV provides on-premises, hands-on QMS establishment and maintenance services.
Production Lines
QWV supports organization’s efforts to establish a valid production line.
​
QMS Audits
QWV shall prepare the organization for selected QMS audits, along with Internal Audits and Supplier’s Audits.
Regulatory Submissions
QWV assistance to the organization for successful regulatory submissions (FDA-510(k), EU-MDR, AMAR…)
Trainings
QWV provides a handful variety of training related to quality assurance and regulatory affairs in the medical devices field.
You may find interested in one (or more) of the following trainings and workshops:
-
EN-ISO13485: 2016 – Quality Management Systems for the Medical Devices Industry
-
Bulletproof CAPA?
-
EU 2017/745 – The New European Medical Devices Regulation
-
Production Process Validation – How to do it Right?
-
Cost of Quality – How your QMS Saves the Organization Money?
-
Medical Devices Requirements for Design and Development
Leadership to Excellence
27
Years of Experience
and Still Going
3
Services
Categories
1
Holistic
Capability
24
Around
the Clock
Our Projects
Upcoming Webinars
Thursday, May 18, 2023
01:00 PM PST | 02:00 PM EST
Speker: Yuval Shapiro