ISO 13485:2016

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) in the medical device industry. It ensures organizations meet regulatory requirements for the design, production, and distribution of medical devices. The standard focuses on risk management, process control, and continuous improvement to enhance product safety and effectiveness.

ISO 14971:2019 & ISO 24971:2020

ISO 14971:2019 is the international standard for risk management in the medical device industry. It provides a structured framework for identifying, evaluating, and controlling risks throughout a device’s lifecycle. The standard ensures manufacturers proactively manage safety and regulatory compliance to minimize harm to patients and users.

ISO 24971:2020 provides guidance on applying ISO 14971:2019

EU MDR 2017/745 QMS

EU MDR 2017/745 QMS outlines the quality management system requirements for medical device manufacturers selling in the European market. It ensures compliance with stricter safety, performance, and post-market surveillance regulations. The regulation emphasizes risk management, clinical evaluation, and traceability to enhance patient safety.

FDA Labeling & UDI (801 & 830)

FDA Labeling & UDI (801 & 830) establishes requirements for medical device labeling and Unique Device Identification (UDI) to improve traceability and patient safety. 21 CFR Part 801 outlines general labeling regulations, while 21 CFR Part 830 defines UDI system rules for device identification and database submission. These regulations help ensure accurate device tracking, reduce errors, and enhance regulatory oversight.

FDA QMS Core (803, 806, Part 7 & 820)

The FDA QMS Core includes regulations such as 21 CFR 803, 806, Part 7, and 820, which govern quality management systems for medical devices in the U.S. It covers essential requirements for reporting adverse events, handling recalls, and maintaining a compliant QMS. These regulations ensure medical device manufacturers meet FDA standards for safety, performance, and regulatory oversight..

Note: 820 & EU MDR do not include a full ISO 13485 assessment too

FDA Part 11

FDA Part 11 establishes regulations for electronic records and electronic signatures in the pharmaceutical, biotech, and medical device industries. It ensures that digital records are trustworthy, secure, and compliant with FDA regulations. The rule aims to maintain data integrity, confidentiality, and accountability throughout the product lifecycle.

ISO 17025

ISO 17025 is an international standard that specifies the requirements for the competence of testing and calibration laboratories. It ensures that labs consistently produce valid and reliable results through robust quality management systems and technical expertise. The standard covers areas like equipment, personnel, and procedures to guarantee accuracy and reliability in testing and calibration activities.

ISO 10993

ISO 10993 is a series of international standards that provide guidelines for the biological evaluation of medical devices. It assesses the potential risks of medical devices in terms of their biological compatibility with the human body. The standard helps ensure that devices are safe and effective for patient use, focusing on factors like cytotoxicity, irritation, and sensitization.

ISO 9001

ISO 9001 is an international standard for quality management systems (QMS) that focuses on ensuring consistent product and service quality. It emphasizes customer satisfaction, continuous improvement, and meeting regulatory requirements. The standard is applicable to organizations of all sizes and industries, aiming to enhance operational efficiency and effectiveness.

EU MDR 2017/745 Technical Documentation

EU MDR 2017/745 Technical Documentation outlines the requirements for medical device manufacturers to demonstrate compliance with European Union regulations. It includes detailed information on product design, development, performance, and safety, ensuring devices meet the necessary standards for market approval. The documentation must be maintained and updated throughout the product lifecycle to ensure ongoing compliance.

Health Canada SOR/98-282

Health Canada SOR/98-282 is the Medical Device Regulations (MDR) that govern the sale, import, and manufacturing of medical devices in Canada. It sets out the requirements for device classification, licensing, quality management systems, and post-market surveillance. Compliance with SOR/98-282 ensures that medical devices meet safety, effectiveness, and performance standards for the Canadian market.

HIPAA as a BAA

HIPAA (Health Insurance Portability and Accountability Act) as a Business Associate Agreement (BAA) outlines the legal responsibilities of third-party vendors handling protected health information (PHI) on behalf of healthcare entities. It ensures that vendors comply with HIPAA’s privacy and security requirements to protect patient data. The BAA establishes safeguards, breach notification procedures, and penalties for non-compliance.