ISO 13485 Transition Services in California

 Is your California based organization looking to start the ISO 13485 transition? Core Compliance provides ISO 13485 transition services in California. ISO 13485:2016 is the most recent development 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 ISO 13485 transition requirements in as little as 30 days.

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)

California Regulatory Medical Device Consultants

We have experienced California 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 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 has regulatory medical device expertise that evaluate 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 distrusting 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 to ISO 13485:2016  FDA 21 CFR 820.30

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 

ISO Standards

Core Compliance has expertise in the following ISO standards:

ISO 9001:2015 –Quality Management Systems
ISO 13485:2016 FDA Compliance 510K Submission CE Marking –Medical Devices Quality Management Systems
ISO 17025–Testing & Collaboration Laboratories Management
AS 9100–Aerospace Industry Quality Management Systems
ISO/IEC 20000:2011–Information Technology Service Management
ISO/IEC 27001:2011–Information Technology Security Management
R2:2013 RIOS Electronics Recycling NAID -Information Destruction e-Stewards –Responsible Recycling and Reuse of Electronics
ISO 14001- Environmental Management Systems
OHSAS 18001 ISO 45001 –Occupational Health & Safety Management
ISO/TS 16949-Automotive Industry Quality Management Systems