ISO 13485 Certification Process
Core Compliance takes the headaches for medical device companies looking for a straight forward approach to the ISO 13485 Certification process, in developing a quality management system that meets FDA & ISO 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 compliance in as little as 60-90 days.
ISO 13485:2016 Update
Is your Medical Device organization looking to transition to ISO 13485:2016 update? This is the most recent development since 2003 & there are important reasons to stay in compliance in keeping up with changes in the industry. You have until January 1st 2019 to make the transition.
Core Compliance consultants have 30 years experience in the medical device industry with straight forward approach in implementing requirements with the changes to you’re Medical Device/Manufacturing organization.
Key changes to ISO 13485:2016 to align with your current QMS:
- QMS Aligns with Regulations, Framework
- Design Controls & Risk Management
- Aligned with FDA regulations to FDA 21 CFR Part 820 (See requirements CFR – Code of Federal Regulations Title 21)
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
Experienced 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