Blog
Medical Device Audit Readiness: Why Preparing for a Medical Device Audit Shouldn’t Be Necessary
Discover why constant medical device audit readiness is essential. Learn how a well-designed QMS and a culture of compliance can eliminate the stress of last-minute audit preparations and ensure ongoing compliance. Drive your audit success with these actionable insights.
The Critical Role of Medical Device Audit Compliance: Why Regular Audits Are Necessary
Learn why medical device audit compliance is essential for maintaining quality and safety. Explore the benefits of regular audits and how to strengthen your medical device compliance process.
FDA Breakthrough Device Designation: Benefits, Criteria, and Application Process
Discover the benefits, criteria, and application process for the FDA Breakthrough Device Designation for medical devices. Learn how Fission Consulting can guide your innovative medical device to market faster.
The Complete 7-Step CAPA Process for Medical Devices
Learn the essential steps of the CAPA process for medical devices to ensure compliance and improve product quality. Discover best practices and actionable strategies to effectively implement a CAPA system.
The Top 8 Threats and Challenges of AI in SaMD
Explore the transformative role of AI in SaMD. Discover the opportunities Artificial Intelligence presents, from enhanced diagnostics to personalized treatment plans, and learn about the key threats and challenges for consideration and successful implementation.
Lean Product Development for Medical Devices: Accelerating Innovation and Reducing Costs
Discover how lean product development can streamline the process for medical devices, reducing waste and accelerating time-to-market. Learn key strategies and actionable steps to implement lean product development for medical devices.