Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Quality Assurance

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...

Quality Control

Quality Control

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...

Introduction to Statistical Process Control

Introduction to Statistical Process Control

Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...

Good Manufacturing Practices

Good Manufacturing Practices

Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...

Hazard Analysis and Critical Control Points (HACCP)

Hazard Analysis and Critical Control Points (HACCP)

Hazard Analysis and Critical Control Points (HACCP) is a science-based, preventive system used globally to ensure food safety by identifying, evaluating, and controlling biological, chemical, and physical hazards throughout food production. Originally developed by NASA and the Pillsbury Company for astronaut food, HACCP is now a core component of the Codex Alimentarius.HACCP operates on prerequisite programs—such as Good Manufacturing Practices (GMPs), sanitation procedures, and supplier...

Propagation of Uncertainty from Systematic Error

Propagation of Uncertainty from Systematic Error

The atomic mass of an element varies due to the relative ratio of its isotopes. A sample's relative proportion of oxygen isotopes influences its average atomic mass. For instance, if we were to measure the atomic mass of oxygen from a sample, the mass would be a weighted average of the isotopic masses of oxygen in that sample. Since a single sample is not likely to perfectly reflect the true atomic mass of oxygen for all the molecules of oxygen on Earth, the mass we obtain from this particular...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same authorSame journal

US regulation of combination products.

Medical device technology·2010

Same author

Clinical studies in Italy.

Medical device technology·2010

Same author

Meeting US and European supplier control requirements.

Medical device technology·2009

Same author

Addressing Eeuropean environmental legislation.

Medical device technology·2009

Same author

Addressing US and European device testing requirements.

Medical device technology·2008

Same author

New Italian device registration requirements.

Medical device technology·2008

Search research articles

Related Experiment Video

Updated: Jun 23, 2026

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control

Published on: August 29, 2025

Avoiding surprises when implementing a single quality system.

¹Donawa Consulting, Rome, Italy. medonawa@donawa.com

Medical Device Technology

|May 2, 2009

Summary

This summary is machine-generated.

European medical device manufacturers must meet both European and United States quality system requirements. Operating under International Organization for Standardization (ISO) 13485 alone is insufficient for US compliance.

Related Experiment Videos

Last Updated: Jun 23, 2026

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control

Published on: August 29, 2025

Area of Science:

Medical device regulation
Quality management systems

Background:

International medical device manufacturers often face complex regulatory landscapes.
Compliance with International Organization for Standardization (ISO) 13485 is a common quality standard.
United States (US) Food and Drug Administration (FDA) regulations present unique quality system requirements.

Purpose of the Study:

To highlight critical differences between European and US quality system requirements for medical devices.
To provide guidance for manufacturers operating a single quality system for both markets.
To ensure comprehensive compliance for medical device market access.

Main Methods:

Comparative analysis of ISO 13485 and US FDA 21 CFR Part 820.
Identification of key areas of divergence in quality system expectations.
Discussion of strategies for integrating regulatory requirements.

Main Results:

ISO 13485 alone does not fully address US FDA quality system mandates.
Specific US requirements, such as those related to complaint handling and corrective actions, necessitate additional considerations.
A unified quality system requires careful planning to bridge regulatory gaps.

Conclusions:

Manufacturers must proactively address US FDA requirements beyond ISO 13485.
Implementing a robust, integrated quality management system is crucial for dual-market compliance.
Understanding and mitigating regulatory differences ensures successful market access in both Europe and the US.