ISO Services
Why should I certify my product with ISO?
For companies wanting to begin marketing their medical device products in Canada and the United States, you will need to have documented procedures in place as required by Health Canada Medical Device Regulations (MDRs) and FDA 21CFR 820 Quality System Regulations.
Obtain ISO Certification and ensure your products meet key standards.
Our team offers the following ISO Certification services:
Creation and/or review of Quality Management System (QMS):
Development of procedures and associated forms
Implementation of the QMS and subsequent training of staff
Learn more about our Quality Assurance here.
MDSAP Certification Audit (ISO 13485 in Canada)/Certification Audits for other ISOs
Obtain and schedule audit organization
Perform mock audit prior to actual audit
Support and host the audit, provide assistance with responding to audit findings and implementing corrective actions to address audit findings
CDS ISO Certifications
ISO 14971
ISO 14971 is the standard used for medical devices, including software as a medical device (SaMD) and in vitro medical devices, throughout their lifecycle.
ISO 14155
ISO 14155 is the standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations involving medical devices in human subjects (following Good Clinical Practice (GCP)).
ISO 9001
ISO 9001 is an internationally recognized standard for quality management that helps organizations across various industries enhance their performance, fulfill customer needs, and show their dedication to quality. The standard outlines the steps required to establish, implement, maintain, and continuously improve a quality management system (QMS). Adopting ISO 9001 means your organization has set up efficient processes and trained personnel to consistently deliver high-quality products or services.
ISO 13485
ISO 13485 is a globally accepted standard for quality management systems in the development and production of medical devices. It specifies requirements that assist organizations in ensuring their medical devices comply with both customer expectations and regulatory standards for safety and effectiveness. Both Health Canada and the FDA require medical device manufacturers to hold a Certificate of Registration as evidence of their quality system compliance with ISO 13485. Verifying that the manufacture is conforming to ISO 13485 requirements, MDRs and 21 CFR 820 is assessed using the Medical Device Single Audit Program (MDSAP) in Canada.