ISO 13485 – Certification for Medical Device Manufacturers
A Quality Management System
ISO 13485 Certification Benefits
Small businesses may gain a number of benefits from an ISO 13485:2016 certification:
- Foundation for establishing compliance with FDA, MDD or CE requirements
- Ensure QMS practices that produce consistently safe and effective medical devices
- Helps you manage risk effectively
- Provides for the opportunity to improve QMS processes and efficiencies
- Creates opportunities to gain new business within medical device industries
- Essential controls to ensure product conformity and regulatory compliance
The new ISO 13485 emphasizes risk management and risk-based decision making for processes outside the realm of product realization. The focus is on safety and performance of medical devices and compliance with regulatory requirements.
The ISO 13485 is a stand-alone standard. It is similar in scope and intent to ISO 9001.
Consulting Support for ISO 13485
Core Business Solutions has qualified ISO 13485 consultants ready to help you achieve certification. Support for the ISO 13485 standard is available through all of our Online and Onsite Consulting Programs. We also provide consulting support for companies seeking multiple certifications.
Our consultants translate the technical language of the standard into Plain English and make it as simple and effective for your organization as possible. Implemented properly, ISO 13485 gives you a continual return on your investment.
For more information about ISO certification for the 13485 standard, please call our consulting office at 866-354-0300, or email firstname.lastname@example.org.
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If you would like any additional information about our ISO certification consulting programs, or would like a quote for any of these options, please give us a call or send a quick email. We’re also glad to answer any ISO questions you may have.
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