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

Non-ohmic Devices

Non-ohmic Devices

In most substances, the current flow is proportional to the voltage applied to it. A simple relationship between the values of current, voltage, and resistance is known as Ohm's law. Nonohmic devices do not exhibit a linear relationship between voltage and current. One such device is the semiconducting circuit element known as a diode. A diode is a circuit device that allows current flow in only one direction.
Consider a simple circuit consisting of a battery, a diode, and a resistor. A diode...

Clinically Relevant Drug Product Specifications: Methods of Establishment

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...

Testing Water Quality

Testing Water Quality

When the quality of water for concrete preparation is uncertain, its impact on the setting time of cement and compressive strength of mortar is assessed by comparison with de-ionized or distilled water benchmarks. American Society for Testing and Materials (ASTM) C1602 requires the setting times to be within 90 minutes of the control, British Standard (BS) 3146:1980 allows a 30-minute variance in the initial setting, while British Standards European Norm (BS EN) 1008 specifies initial setting...

Design Example: Resistive Touchscreen

Design Example: Resistive Touchscreen

A device engineer plays a crucial role in designing user interfaces for mobile devices. One such interface is the resistive touchscreen, which fundamentally consists of two metallic layers: a flexible upper layer and a rigid lower layer, separated by a narrow gap. The high resistance between these two layers is a key characteristic of this design.
When a user touches the screen, the two layers make contact at a specific point known as the touchpoint. This contact reduces the resistance between...

Legal Guidelines for Documentation

Legal Guidelines for Documentation

The legal guidelines for nursing documentation are essential for ensuring accurate, professional, and ethical recording of patient care. The guidelines are discussed here:

Pilot and Numeric Relaying

Pilot and Numeric Relaying

Pilot relaying is a type of differential protection used in power systems. It compares electrical quantities at the terminals of equipment via a communication channel instead of direct relay interconnection. This method is essential for transmission lines where the terminals are far apart, typically up to 80 km for lines with 69 to 115 kV ratings. Four types of communication channels are used for pilot relaying:

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

Avoiding surprises when implementing a single quality system.

Medical device technology·2009

Same author

Addressing Eeuropean environmental legislation.

Medical device technology·2009

Same author

New Italian device registration requirements.

Medical device technology·2008

Search research articles

Related Experiment Video

Updated: Jun 28, 2026

Implementation of Portable Emissions Measurement Systems (PEMS) for the Real-driving Emissions (RDE) Regulation in Europe

Implementation of Portable Emissions Measurement Systems (PEMS) for the Real-driving Emissions (RDE) Regulation in Europe

Published on: December 4, 2016

Addressing US and European device testing requirements.

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

Medical Device Technology

|October 25, 2008

Summary

This summary is machine-generated.

Medical device companies must understand US and European testing differences to avoid costly redesigns and retesting. Early awareness of regulatory variations ensures smoother market entry and compliance.

More Related Videos

A 3D-printed Chamber for Organic Optoelectronic Device Degradation Testing

A 3D-printed Chamber for Organic Optoelectronic Device Degradation Testing

Published on: August 10, 2018

Fabrication of Microscope Stage for Vertical Observation with Temperature Control Function

Fabrication of Microscope Stage for Vertical Observation with Temperature Control Function

Published on: July 31, 2019

Related Experiment Videos

Last Updated: Jun 28, 2026

Implementation of Portable Emissions Measurement Systems (PEMS) for the Real-driving Emissions (RDE) Regulation in Europe

Implementation of Portable Emissions Measurement Systems (PEMS) for the Real-driving Emissions (RDE) Regulation in Europe

Published on: December 4, 2016

A 3D-printed Chamber for Organic Optoelectronic Device Degradation Testing

A 3D-printed Chamber for Organic Optoelectronic Device Degradation Testing

Published on: August 10, 2018

Fabrication of Microscope Stage for Vertical Observation with Temperature Control Function

Fabrication of Microscope Stage for Vertical Observation with Temperature Control Function

Published on: July 31, 2019

Area of Science:

Medical Device Regulation
International Compliance
Product Development

Background:

Medical device companies face complex regulatory landscapes when seeking market approval in different regions.
United States and European regulatory requirements for medical devices often present significant, yet sometimes overlooked, differences.
Failure to account for these discrepancies can lead to substantial financial and time-related setbacks.

Purpose of the Study:

To highlight key differences between United States and European medical device testing requirements.
To provide actionable strategies for medical device manufacturers to avoid costly retesting and redesign.
To enhance understanding of international regulatory compliance for medical devices.

Main Methods:

Comparative analysis of United States and European medical device testing standards.
Review of common pitfalls and challenges encountered by manufacturers.
Identification of best practices for navigating regulatory differences.

Main Results:

Significant variations exist in testing protocols, documentation, and approval pathways between the US and EU.
Non-compliance due to overlooked differences results in extended timelines and increased development costs.
Proactive identification and management of these regulatory disparities are crucial.

Conclusions:

Medical device companies must prioritize understanding and addressing US-EU regulatory testing differences.
Strategic planning and early assessment can mitigate risks associated with international market entry.
Adherence to distinct regional requirements is essential for efficient product commercialization.