SERVICES

SERVICES

Quality Assurance

Our Quality Assurance motto:

 

Choose your battles so that you can win the war

 

In a competitive environment with frequent design changes and multiple issues with production, suppliers, corrective actions, new regulations, partner audits etc. – you must be smart with the limited resources that you have.

We’ll be glad to help you and share our insights on best practices.

Mentoring and Training

There is a shortage of well trained and experience QA/RA personnel.

Training is our means to better ourselves through training others. If you have new employees or individuals that you would like to move to QA or RA department, we’d be honored to help you equip them.

Regulatory Affairs

Our Regulatory Affairs motto:

 

Write plainly and walk them through the process

 

Regulatory affairs is the art of producing a compelling submission package that meets all the applicable regulatory requirements. It is a process which takes a lot of thought, strategy, and refining until it’s ready.

We have the skills and experience it takes and would love to help you with your regulatory submissions.

Audits and Audit Support

Audits are inevitable and require a lot of effort to prepare and manage the front/back room dynamics.

What you really want to get out of it is objective and constructive feedback.

We can help you achieve just that through internal audits, mock inspections, and preparation for external audits.

About

About

Principle consultant & CEO
Shimon Vaknin brings 20 years of experience with a variety of medical device companies. His experience includes management of quality systems and successful regulatory submissions to FDA, CE, Canada, Latin America, and Asian countries. He is a certified Quality Auditor, Quality Engineer and Manager of Quality and Organizational Excellence from the American Society for Quality (ASQ), and is Regulatory Affairs Certificated (RAC-US) by the Regulatory Affairs Professional Society (RAPS).
AREAS OF EXPERTISE
• Experienced with a variety of medical specialties, including nuclear medicine, gastroenterology, pulmonology, medical esthetics, cardiology, computed tomography, infusion pumps, and pain
management systems
• Successful regulatory submissions to FDA (Class I, II), CE (Class I, IIa, IIb), Canada (class II, III), AMAR, as well as successful collaborations with agencies in Latin America and Asia
• Setup, certification and ongoing management of Quality Systems
• Internal & external audits per ISO 13485, FDA QSR, MDD, and MDSAP
• Supporting R&D activities in all the aspects of design controls
• Training and mentoring for new and experienced employees
WORK

WORK

Clients and businesses we worked for:

Contact

Contact

Call Us +972-54-2657101 Monday–Friday | 9am–5pm (GMT +1)

Visit Us Hamapilim 4, Nesher, Israel

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