In Compliance Magazine

FDA Warns Manufacturers to Scrutinize Third-Party Testing Data

The U.S. Food and Drug Administration (FDA) is reminding medical device manufacturers to independently verify testing results generated by third parties that are included in premarket submissions to the agency. In a Letter to Industry issued on February 20, the FDA notes that it has observed an increase in recent years of contracted third-party testing […]

The post FDA Warns Manufacturers to Scrutinize Third-Party Testing Data appeared first on In Compliance Magazine.

EMC & eMobility

For a company embarking on EMC testing for either component or vehicle-level testing of their EV products, it is necessary first to have a good understanding of the EMC regulatory situation. Although some of the EMC testing of EVs remains identical to that of their combustion engine equivalents, additional testing of EV motors, EV batteries, and EV charging stations is now required. Existing EMC facilities may need to be upgraded or new ones specifically designed to carry out such tests, and this white paper will take the reader through the details of these needs.

The post EMC & eMobility appeared first on In Compliance Magazine.

FCC Adopts Rules to Enable Consumers to Stop Robocalls, Robotexts

As part of its ongoing effort to stem the rise in unwanted robocalls and robotexts, the U.S. Federal Communications Commission (FCC) has adopted new rules that give consumers more tools to fight back. According to the Report and Order issued on February 16, the new rules required that originators of robocalls and robotexts comply with […]

The post FCC Adopts Rules to Enable Consumers to Stop Robocalls, Robotexts appeared first on In Compliance Magazine.

Vitrek Hires New President Gary Schafer to Build Synergies Among Company’s Signature Brands Used in Key Industries

Vitrek has announced the appointment of Gary Schafer as the company’s new president. Vitrek has also appointed Michelle Sweetman as head of marketing based on her success in corporate rebranding.

The post Vitrek Hires New President Gary Schafer to Build Synergies Among Company’s Signature Brands Used in Key Industries appeared first on In Compliance Magazine.

EU Commission Issues Regulations for Cybersecurity Certification Scheme (EUCC)

The Commission of the European Union (EU) has published detailed regulations for the cybersecurity certification of certain products, taking the next step in implementing an EU-wide cybersecurity certification scheme (EUCC) for information and communication technology (ICT) systems and products. Published in the Official Journal of the European Union in early February, Commission Implementing Regulation (EU) […]

The post EU Commission Issues Regulations for Cybersecurity Certification Scheme (EUCC) appeared first on In Compliance Magazine.

Military and Aerospace EMC: What is the RTCA?

Greetings. I am Patrick André, an independent EMC consultant in the Pacific Northwest. Having spent my career in EMC design, testing, and troubleshooting, mainly in the aerospace and military industries, I have had a chance to answer many questions. In this blog, I’ll address some of those questions and share some unique aspects of EMC […]

The post Military and Aerospace EMC: What is the RTCA? appeared first on In Compliance Magazine.

FDA Amends Quality System Regulations for Medical Devices

In an effort to stay current with new and updated international standards, the U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices. In a Final Rule published in early February in the Federal Register, the FDA amended its current good manufacturing practice (CGMP) requirements for […]

The post FDA Amends Quality System Regulations for Medical Devices appeared first on In Compliance Magazine.

EU Commission Issues Regulations for Cybersecurity Certification Scheme (EUCC)

The Commission of the European Union (EU) has published detailed regulations for the cybersecurity certification of certain products, taking the next step in implementing an EU-wide cybersecurity certification scheme (EUCC) for information and communication technology (ICT) systems and products.

Published in the Official Journal of the European Union in early February, Commission Implementing Regulation (EU) 2024/482 lays out the structure of the common criteria and common evaluation methodology underlying the EUCC, consistent with the framework originally set out by the Commission in 2019. Specifically, the Implementing Regulation details the specific standards and requirements for the evaluation of ICT products, the information necessary for certification, and marking and labeling requirements.

The Implementing Regulation also provides information on conformity assessment bodies certifying devices under the EUCC, post-certification compliance and monitoring, and the consequences for the identification of non-conforming products.

Read the EU Commission’s Implementing Regulation detailing the regulations under the EU’s cybersecurity certification scheme as published in the Official Journal of the European Union.

The post EU Commission Issues Regulations for Cybersecurity Certification Scheme (EUCC) appeared first on In Compliance Magazine.

Military and Aerospace EMC: What is the RTCA?

Greetings. I am Patrick André, an independent EMC consultant in the Pacific Northwest. Having spent my career in EMC design, testing, and troubleshooting, mainly in the aerospace and military industries, I have had a chance to answer many questions. In this blog, I’ll address some of those questions and share some unique aspects of EMC in the military and aerospace field. Let me know if there is a specific aspect of this field you would like to see covered. Let’s begin.

One question I have heard is, “What is the RTCA?” In the EMC field, most people know the RTCA as the group that creates the aeronautic environmental standard DO-160. However, beyond establishing tests and test levels for environmental testing of avionics, the RTCA’s work reaches far beyond DO-160.

The Radio Technical Commission for Aeronautics, now known as RTCA, was established in 1935 with a focus on the standardization and assurance of safety of radio communication and radar systems. This led to other developments, such as a common system for air traffic controllers across the United States. The work is not specifically performed by the RTCA but rather by groups and committees of industry experts and specialists in a specific field. In doing so, industry has a direct say in how standards are established while recognizing that the quality of these standards must be maintained at a high level.

The RTCA is a private, not-for-profit organization and not an agency of the US Government. The organization covers the hardware and software used for flight control and navigation, collision avoidance, audio systems, night vision systems, flight deck displays, weather detection, among other areas. For example, portable electronics used by passengers and flight crew must also be researched and regulated for safe use on commercial aircraft and to ensure that avionics are not affected.

The RTCA has members from over 460 commercial aerospace companies and other interested corporations and groups. The standards, operational situations, architectures, and other documents that are within RTCA’s control are in the form of Minimum Aviation System Performance Standards (MASPS), Minimum Operational Performance Standards (MOPS), Safety & Performance Requirements (SPR), Interoperability Requirements (INTEROP) and other publications. There are about 500 documents currently available from the RTCA, with many available in either hard copy or electronic format.

The RTCA works with the FAA in the United States and with EUROCAE – The European Organization for Civil Aviation Equipment. EUROCAE and the RTCA often work in cooperation with each other to create common standards and regulations. For example, DO-160 in the United States has a EUROCAE counterpart, ED-14, which both groups have agreed to in totality.

Committee meetings are typically open to the public. However, voting and suggestions for changes are allowed only by members of the RTCA. However, input from all aspects of the aerospace industry is welcomed.

The website for the RTCA is available here.

Next month, we will look at DO-160 specifically, its development, and the upcoming revision.

The post Military and Aerospace EMC: What is the RTCA? appeared first on In Compliance Magazine.

FDA Amends Quality System Regulations for Medical Devices

In an effort to stay current with new and updated international standards, the U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

In a Final Rule published in early February in the Federal Register, the FDA amended its current good manufacturing practice (CGMP) requirements for its quality system (QS) regulation applicable to medical device manufacturers. The amended requirements now incorporate by reference ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. The FDA says that the change is part of its effort to harmonize its quality management systems requirements for medical devices with those adopted by other regulatory agencies.

The FDA’s final rule regarding the changes to its current CGMPs takes effect on February 2, 2026. Until then, device manufacturers must continue to comply with the FDA’s QS regulation.

Read the FDA’s quality system regulation amendment as published in the Federal Register.

The post FDA Amends Quality System Regulations for Medical Devices appeared first on In Compliance Magazine.

U.S. and EU Sign Joint Cybersafe Products Action Plan

The U.S. and the European Union (EU) have signed an agreement to work collaboratively to strengthen the cybersecurity of Internet-of-things (IoT)-capable hardware and software products used by consumers.

According to a joint press statement issued in late January by the European Commission and the White House National Security Council, the Joint Cybersafe Products Action Plan is intended to foster technical cooperation between the U.S. and the EU, in an effort to align their respective cybersecurity requirements. The ultimate goal of the Joint Action Plan is for the signatories to achieve mutual recognition of cybersecurity labeling programs and regulations for IoT devices.

The Joint Cybersafe Products Action Plan was immediately endorsed by Jessica Rosenworcel, Chair of the U.S. Federal Communications Commission (FCC). In a separate statement, Rosenworcel referenced the FCC’s efforts to establish its own cybersecurity labeling program, building on work by the National Institute of Standards and Technology (NIST), and welcomed the opportunity to actively collaborate with their counterparts in the EU to reduce unnecessary cyber risks for consumers.

Read the joint press statement issued by the U.S. and EU about the Joint Cybersafe Product Action Plan.

Read Rosenworcel’s remarks about the U.S./EU Action Plan.

The post U.S. and EU Sign Joint Cybersafe Products Action Plan appeared first on In Compliance Magazine.

Pages