What are FDA Requirements for Reusable Medical Devices
Clear, FDA-aligned guidance on how reusable medical devices must be cleaned, disinfected, or sterilized for 510(k) or PMA clearance. Learn Spaulding classification rules, validatio
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LinkedIn Pulse Axis Medical Device Consulting helps startups and manufacturers navigate FDA 510(k), De Novo, and ISO 13485 pathways with clarity and confidence.
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FDA Issues Draft Guidance on QMSR Information for Premarket Submissions
FDA issues draft guidance on QMSR information for medical device manufacturers, aligning 21 CFR Part 820 with ISO 13485:2016. Learn key documentation requirements and 2026 complian
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FDA Quality System Requirements for Clearance
Learn whether medical device manufacturers need a full QMS for FDA 510(k) clearance, key design control and risk management requirements, and how Pulse Axis Medical Device Consulti
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Wireless Testing Requirements for Medical Devices in the U.S.
Discover FDA and FCC wireless testing requirements for U.S. medical devices—covering coexistence, EMC, cybersecurity, and performance validation.
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Software Documentation Requirements for Medical Devices in the United States
Concise guide to FDA software documentation requirements for U.S. medical devices—learn key elements for compliance and successful submissions.
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Predicate devices in the 510(k) pathway: how to choose them—and prove Substantial Equivalence
Guide to predicate devices for 510(k): how to choose, avoid split predicates, align with FDA-recognized standards, and demonstrate Substantial Equivalence.
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Driving Innovation in Medical Devices Through Expert Consulting
Medical device consulting helps innovators navigate FDA and EU MDR regulations, streamline product development, and accelerate market success with expert guidance.
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510(k) Submission for First-Time Medical Device Startups (2025): A Step-by-Step Consulting Playbook
First-time founder’s playbook to plan, build, and submit a Class II 510(k). Timelines, testing, documents, and common pitfalls—explained for startups in 2025.
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