Compliance & Regulation Archives

How to Overcome Development Challenges: Proving Regulatory Compliance in Complex Product and Systems Development

July 24, 2024 in Compliance & Regulation /by Mario Maldari

How to Overcome Development Challenges: Proving Regulatory Compliance in Complex Product and Systems Development As we enter the second half of 2024, development of complex products and systems often encounters the intricate web of regulatory compliance. From medical devices and automotive components to aerospace systems and software applications, ensuring adherence to stringent regulations is critical […]

Simplify Audit Documentation by Leveraging the Power of an Itemized Database

July 23, 2024 in Compliance & Regulation, Jama Software Company and Community News, Product Development & Management Medical Device & Life Sciences /by Jama Software

Simplify Audit Documentation by Leveraging the Power of an Itemized Database How to enhance efficiency, auditability, and stay ahead of the competition with Jama Connect® for Medical Device Development In the current landscape of medical device and life sciences development — in addition to facing relentless pressures to innovate, remain competitive, and release quality products […]

The Top Six Things You Should Know About TÜV SÜD

July 22, 2024 in Compliance & Regulation /by Mario Maldari

The Top Six Things You Should Know About In the quest for innovation, product testing, compliance, and safety certifications remain key to accessing markets and gaining customers. No one wants to buy a product, service, or process that hasn’t been thoroughly vetted by an independent body. In the context of global markets, few certifications carry […]

Navigating the Shift: From Machinery Directive 2006/42/EC to Machinery Regulation EU 2023/1230

June 27, 2024 in Compliance & Regulation Automotive /by Jama Software

. Navigating the Shift: From Machinery Directive 2006/42/EC to Machinery Regulation EU 2023/1230 Change is inevitable, especially in regulatory frameworks governing industries. In Europe, the transition from the Machinery Directive 2006/42/EC to the new Machinery Regulation EU 2023/1230 marks a significant step forward in ensuring safety, innovation, and harmonization in the machinery sector. This transition […]

IVDR Common Errors: Navigating Notified Body Expectations

June 25, 2024 in Compliance & Regulation Medical Device & Life Sciences /by Jama Software

IVDR Common Errors: Navigating Notified Body Expectations Explore the notified body process and IVDR technical documentation with experts Margot Borgel, Director of IVD Global Regulatory Affairs at RQM+, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®. You will gain a thorough understanding of these topics and more: The notified body’s approach to […]

Ensuring Quality and Reliability in Automotive Software Development: An Overview of ASPICE 4.0

June 18, 2024 in Compliance & Regulation Automotive /by Jama Software

Ensuring Quality and Reliability in Automotive Software Development: An Overview of ASPICE 4.0 ASPICE (Automotive SPICE) 4.0 is a process assessment model tailored specifically for the automotive industry to ensure the quality and reliability of software and system development processes. It is part of the larger ISO/IEC 330xx family of standards and is derived from […]

3 Lessons Learned From EU MDR Implementation To Ensure IVDR Adoption

May 29, 2024 in Compliance & Regulation Medical Device & Life Sciences /by Jama Software

3 Lessons Learned From EU MDR Implementation To Ensure IVDR Adoption In the previous article, “How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint,” we discussed key factors for maintaining operational excellence to achieve cost reduction, enhanced compliance, and support global footprint. In this article, we shift our focus toward […]

Mastering ISO/IEC 27001: A Guide to Information Security Management

May 22, 2024 in Compliance & Regulation, Cybersecurity /by Jama Software

Mastering ISO/IEC 27001: A Guide to Information Security Management Understanding Information Security Management Information security, often referred to as cybersecurity, is a critical aspect of modern technology and business operations. It encompasses the protection of sensitive data, systems, and networks from unauthorized access, disclosure, disruption, modification, or destruction. The evolution of information security practices has […]

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests

May 14, 2024 in Compliance & Regulation Medical Device & Life Sciences /by Jama Software

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns […]

What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security

May 7, 2024 in Compliance & Regulation Medical Device & Life Sciences /by Jama Software

What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security Managing risk around a medical device’s entire lifecycle has become increasingly complex. Many devices use third-party components, which is especially true for devices that require a network to operate. This increased need for connectivity, along with other emerging threats, is putting security at the […]

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Category: Compliance & Regulation