ISO 13485 Certification
Is your organization looking to obtain ISO 13485 certification, our consultants specialize in working with medical device manufacturers, distributors & contract manufacturers to get certified as soon as 60-90 days.
ISO 13485:2016 Standard outlines quality management system specific to the medical devices industry, international standard outlining the requirements at every step of a product’s life cycle, including design & development, production, storage, servicing, installation and distribution. 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 Medical Device Experience
Core Compliance medical device consultants have 30 plus years of experience in the medical industry with straight forward approach in implementing requirements.
Design & Develop Quality Management System:
- QMS Aligns with Regulations, Framework
- Medical Device File (Techncial File)
- Risk Controls (ISO 14971:2019)
- Design Controls
- Medical Device Regulations (MDR) Regulation (EU) 2017/745
- UL Standard (Safety & Compliance)
- ETL Mark (Intertek Testing Labortories)
- Aligned with FDA regulations to FDA 21 CFR Part 820 (See requirements CFR – Code of Federal Regulations Title 21)
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
ISO Standards
