ISO 13485

An ISO 13485 Consulting Firm

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Osamu Sakai

President, Calsak Corporation

We achieved our certification in less than 4 months. Our consultant was very informative and prepared us very well. We highly recommend our consultant for any company that is trying to get ISO certified.

Jerome Liwang

Quality and Production Manager

Thank you for your assistance! We passed our audit with ZERO issues! I appreciate your constant communication and your efforts to make this far easier than I imagined.

Brian Cunningham

CFO, Pronto Wind Solutions

We met our deadline of becoming 9001 certified in two short months. And the price point was very competitive. We are extremely pleased with the professionalism and expertise of our consultant.

Alan Ward

Senior Design Engineer, Carrier

Our certification process took 2 months from start to finish. Our consultant's skills and experience helped us create practical solutions. We had a very positive experience. We would absolutely recommend our consultant to others.

Amelia Manlutac

Accreditation Administrator, Cedars-Sinai Medical Center

With our consultant's help we met our tight deadline and received zero non-conformities!

Tom Ronat

Quality Manager, G-CON Manufacturing

We met our deadline and our consultant was critical in achieving that. Our consultant helped us to identify and fill in gaps and provided valuable insights. I would definitely recommend our consultant to others.

Jerry Young

General Manager, Porvair

Our consultant walked us through the entire process. Without his help, we would not have achieved such a quick certification. Thank you!

Daniel McGinnis

Project Manager, OMNE

We had to be ready for certification in just 3 weeks. Without our consultants help we would have never met our requirements in time. Our consultant was very professional, knowledgeable, prompt, articulate, and understood our needs. I highly recommend!

Scott Campbell

VP Business Development, reLink Medical

Our consultant quickly understood our company and tailored a system to fit our needs. He helped us fill in our gaps and trained our staff on performing audits and how to think about processes. Highly recommend.

Yoedvin Vasquez

Owner, Axcex Media

Our consultant was always there to help us through a quick implementation. We met our deadline and were ready for certification in only 30 days!

Daniel Hester

President, Hester Fabrications

Quick and efficient, mindful of our time but ready to take extra time to explain what we didn't understand. I highly recommend.

Carlos E. Garcia

Vice President, First Class Aviation

Our consultant was professional and down to earth. He was always available to answer questions and was clear with his explanations. I never felt concerned at any point that were would be unprepared for our audit. We were under a tight deadline and we met our goal.

Amin De La Rosa

CEO, Universal Trading Solutions

Great one-on-one service. I would definitely recommend to others.

Karen Rabin

Program Manager

Our consultant was instrumental in our document drafting, and in training our internal auditors. Thank you!

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ISO 13485 - Medical Devices - Quality Management System Requirements

The ISO 13485 standard sets out the requirements for a quality management system specific to the medical device industry. Safety and quality are non-negotiable in the medical device industry. Regulatory requirements are becoming increasingly stringent and organizations are expected to demonstrate their quality management processes and seek out best practices in everything that they do.

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Achieve Results with the Certify Consulting Group

Achieve compliance and certification quickly and affordably
Step-by-step guidance, training, auditing
Custom solutions and documents
Assigned project manager and detailed project plan
Online learning management system included

AS9100, ISO 9001, ISO 13485, ISO 14001, ISO/TS 16949, ISO 17025, ISO 20000, ISO 22301, ISO 22000, FSSC 22000, ISO 22716, ISO 31000, ISO 45001, ISO 50001, SQF Food Safety, BRC Food Safety, R2 Responsible Recycling, eStewards, RIOS Recycling, NAID, SA8000, CMMI, GDPR, ITAR

Consultant Support

The Evata Consulting Group offers a full range of consultant support for your ISO 13485 project. Schedule a free consultation to find the right strategy and approach for you.