Our Services

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.

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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.

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.

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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.

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