ISO 13485 Certification Process

Core Compliance takes the headaches for medical device companies looking for a straightforward approach to the ISO 13485 certification process, in developing a quality management system that meets FDA & ISO requirements. The quality management system is designed and built based upon your scope and compliant to ISO 13485:2016/CFR Part 820 requirements. We build a custom QMS that fits and benefits your organization, rather than just creating more documentation and work.

Core Compliance can help you achieve ISO 13485:2016 compliance in as little as 60-90 days. 

ISO 13485:2016 Update

The FDA amended the title of the Quality System Regulation and established requirements that clarify certain expectations and concepts used in ISO 13485:2016. Published in 2016, ISO 13485:2016 is the third edition of ISO 13485. The review period was then set at the more traditional 5-year period, and thus ISO 13485:2016 is due for another systematic review in 2025.

• ISO 13485:2016 is to be incorporated by reference by the US FDA in February 2026 as part of the amendments to 21 CFR 820
• ISO 13485:2016 A11:2021 is harmonized for the EU MDR 2017/745 and IVDR 2017/746
• ISO 13485:2016 is the basis for the Medical Device Single Audit Program (MDSAP) used by participating members Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agencies Vigilância Sanitária Nacional (ANVISA), Health Canada, Japan’s Ministry of Health, Labor and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the U.S. Food and Drug Administration (FDA)

Core Compliance consultants have 30 years' experience in the medical device industry with straight forward approach in implementing requirements with the changes to your medical device organization.

ISO 13485:2016 Quality Management System

ISO 13485:2016 Quality Management System the standard outlines the requirements for medical devices. International Organization for Standardization (ISO) updated ISO 13485:2016 with a new emphasis throughout the supply chain and product life cycle, as well as device usability and post market surveillance requirements. The FDA has requirements for medical device manufacturers to Quality System Regulation (QSR) is (21 CFR part 820) 

ISO 13485:2016 21 CFR part 820 Compliance

Core Compliance provides regulatory medical device expertise, evaluating the circumstances to define the path for both ISO 13485:2016 certification and FDA 21 CFR Part 820 compliance. Set a a free consultation today to discuss the best plan for your organization. Simply put, organizations selling and distributing medical device products internationally that align with both ISO 13485:2016 and FDA 21 Part 820 compliance will impact global regulatory licenses and can open up international markets. 

Design & Development Guidance

Core Compliance provides ISO/FDA requirements for design & development guidance to ISO 13485:2016 FDA 21 CFR 820.30. The primary focus around medical device design & development is based upon safety, ensure that manufacturer follows all the steps and procedures medical device development, and meet the guidelines to design control. FDA outlines guidelines click here- FDA 21 CFR 820.30 

Design & Development guidance includes:

• Procedure- Documentation all phases in design/development
• Planning-Goals & objectives design/development products
• Inputs- Risk control, sterilization, complaints 

Regulatory Medical Device Consultants

Regulatory Medical Device Consultants that provide a road map to ISO 13485:2016 compliance and FDA 21 CFR requirements with the following services:

• Develop framework FDA 21 CFR QSR regulations
• Develop ISO 13485:2016 Quality Management System 
• Document Control & Records Management & Supplier Management 
• Design control procedures and implementation
• Design control audits
• Design development 
• Design control project management
• DMR (device master record)
• Risk management program development and implementation
• Internal Audit Training

ISO Standards