Isocèle Conseil Support
Since 1999, Isocèle Conseil has been assisting manufacturers, authorized representatives, distributors, importers, and subcontractors of medical devices in establishing, improving, and auditing their quality management systems, in accordance with applicable standards and regulations.
A quality system tailored to medical devices
ISO 13485:2016 is the international standard for quality management systems applicable to medical devices. It defines the requirements that enable an organization to demonstrate its ability to provide medical devices and related services that comply with customer and applicable regulatory requirements.
Implementing a quality system is not limited to drafting procedures. It involves a structured and operational approach that covers, in particular:
- Management’s Responsibility;
- Records management;
- Control over outsourced processes;
- Risk management;
- Design and development;
- Purchasing and supplier management;
- The production and release of products;
- Post-market surveillance;
- Management of complaints, nonconformities, corrective actions, and preventive actions;
- Preparing for audits and inspections.
A Market-Driven Approach to Quality
Depending on the target markets, the requirements applicable to the quality system may vary. A manufacturer seeking to market its medical devices in Canada, the United States, Brazil, Japan, or Australia may be subject to the MDSAP program, a single audit program recognized or used by several regulatory authorities. The MDSAP allows a recognized audit body to conduct a single regulatory audit covering the applicable requirements of the participating authorities.
For the U.S. market, manufacturers must also take into account the FDA Quality Management System Regulation (QMSR), which takes effect on February 2, 2026. The FDA states that this regulation amends the good manufacturing practice requirements applicable to medical devices under 21 CFR Part 820 by incorporating ISO 13485:2016 by reference.
Our Support
Isocèle Conseil helps you define, implement, evaluate, and improve your quality management system, using a pragmatic approach tailored to your organization.
Our services may include, among other things:
- Analysis of the current situation and identification of gaps;
- The implementation or overhaul of the document management system;
- Adapting the quality system to meet the requirements of ISO 13485, MDSAP, or FDA QMSR;
- Preparing for certification audits, supplier audits, or regulatory inspections;
- Conducting internal audits;
- Supporting teams in understanding and implementing the requirements in practice;
- Defining and monitoring quality action plans.
Our goal is to help you build a quality system that is compliant, well-managed, and truly applicable in your teams’ day-to-day work.
Why Choose Isocèle Conseil?
Our expertise combines quality management, regulatory affairs, and operational knowledge of the medical device industry.
When you choose Isocèle Médical, you’ll enjoy:
- A contact person who specializes exclusively in medical devices;
- Personalized and practical support;
- A comprehensive approach that integrates quality, regulatory compliance, and market access strategy;
- A quality system designed to last, evolve, and support your company’s growth.