ISO 13485 Support

Be Sure

Our consultants are experts in ISO 13485 compliance. We stay informed on updates and areas of emerging regulatory scrutiny. If you face stretched resources or demanding timelines, it can be a challenge for your in-house team to track and implement updated standards.  I3 Infotek talent can cost-effectively transform stress to success.

Be Compliant

Does your quality management system comply with ISO 13485:2016 updates?  The new version affects new and renewing certifications. QMS  and other areas of compliance have changed. We can give you peace of mind.

Be Audit-ready

The ISO 13485:2016 transition changed the requirements of the standard. Are your operations compliant with the changes? Our consultants can analyze your development activities and manufacturing validations for ongoing approval by auditors.

How We Can Help

CAPA Corrective Action/Preventive Action

We can provide experts to create, audit or update the CAPA strategy for your medical device. We use proven statistical methods to detect issues. Our experience allows us to guide you to effective corrective and/or preventive actions.

Quality Engineering

Quality engineering is a broad term. There are many aspects of quality engineering required to comply with regulatory standards in manufacturing medical devices. At I3 Infotek, our first priority is to work with you one-on-one to assemble the ideal consulting team for your project.

IQ/OQ/PQ Process Management

Medical device standards for the US, Europe and Canada require that all manufacturing processes be validated. Are your installation, operational and performance qualifications up to speed? Our experts can make sure your IQ/OQ/PQ validations lead the way to compliance.

ISO 13485 Design Controls

Design controls encompass a series of medical development activities. They are part of every quality management system. It is essential to create compliant design controls and ensure your device receives success in meeting ISO 13485:2016 Section 7:3 requirements. Is your in-house team prepared?

Validation Engineering

Validation engineers play an integral role in coordinating processes, systems and equipment used to produce your medical device. Calibrations, settings and durations of design specifications must all be tested. Are you on track?