Compliance & Regulation

  • Risk Management for Class II & III Medical Device Companies

    Risk Management for Class II & III Medical Device Companies

    Medical device companies must evaluate how their development process stands up to the challenge of increasingly connected technologies and strict regulation.

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  • Jama Connect Risk Management Center

    Jama Connect Risk Management Center

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  • Safeguarding Regulated Products Amidst Growing Complexity: A Frost & Sullivan Executive Brief

    Safeguarding Regulated Products Amidst Growing Complexity: A Frost & Sullivan Executive Brief

    Prominent consultancy group Frost & Sullivan describes how Jama Connect can help businesses thrive in safety-critical product markets.

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  • Jama Connect Risk Management Center for Medical Device

    Jama Connect Risk Management Center for Medical Device

    Ease the path to compliance with Jama Connect’s integrated risk management center.

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  • Driving Compliance with Functional Safety Standards

    Driving Compliance with Functional Safety Standards

    This paper looks at the challenges companies face when addressing the intersection of functional safety and efficient, collaborative product development.

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  • Accelerate Medical Device Development While Reducing Risk1:00:07

    Accelerate Medical Device Development While Reducing Risk

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  • Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

    Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

    Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA, and 21 CFR Part 820.

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  • Jama Connect™ Risk Management Center7:37

    Jama Connect™ Risk Management Center

    <p>An integrated solution for guiding medical device risk management.</p>

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  • Security of Medical Devices Remains a Growing Concern

    Security of Medical Devices Remains a Growing Concern

    With the growing amount of connected medical devices, the number of potential targets for hackers and other cyber criminals to exploit continues to rise.

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  • Balancing Compliance and Innovation in Med Device Industry33:49

    Balancing Compliance and Innovation in Med Device Industry

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  • Common Pitfalls of the DHF and How to Avoid Them41:11

    Common Pitfalls of the DHF and How to Avoid Them

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  • Live Traceability: The Golden Key to Proof of Compliance54:29

    Live Traceability: The Golden Key to Proof of Compliance

    A workshop for medical device and life sciences professionals

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  • Understanding ISO 26262 Compliance for Automotive Suppliers1:01:18

    Understanding ISO 26262 Compliance for Automotive Suppliers

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  • Introduction to Risk Management for Medical Devices59:07

    Introduction to Risk Management for Medical Devices

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  • Connecting Requirements to IP: Achieving Requirements Traceability from Ideation through Test28:21

    Connecting Requirements to IP: Achieving Requirements Traceability from Ideation through Test

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  • Requirements Engineering for Safety-Critical Systems 56:02

    Requirements Engineering for Safety-Critical Systems

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  • Jama ISO 26262 Certification and Best Practices for Development 54:38

    Jama ISO 26262 Certification and Best Practices for Development

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  • Top 15 ISO 26262 Snafus: How to Prevent & Mitigate the Mistakes Teams Make

    Top 15 ISO 26262 Snafus: How to Prevent & Mitigate the Mistakes Teams Make

    In this paper Vance Hilderman shares his expert advice on how to prevent or mitigate common ISO 26262 mistakes. Plus, find out what golf and automotive software have in common.

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  • Global Teamwork Goes Under the Microscope

    Global Teamwork Goes Under the Microscope

    Learn about how FEI solved outdated requirements, changing market conditions and insufficient access to requirements in this case study.

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  • DO-254 Benefits Versus Costs for Engineers and Managers

    DO-254 Benefits Versus Costs for Engineers and Managers

    Learn the five levels of design assurance and the benefits of correctly implementing DO-254, ranging from Level A (most critical) to Level E (least critical).

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