Advancements in the healthcare industry have increased wireless, cloud, internet of things (IoT) connected devices, medical devices, and the frequent electronic exchange of medical-device-related health information. Market forces have connected medical devices to PCs, smartphones, and the cloud, with threats, rapidly evolving as interest in healthcare grows.

At Quandary Peak, we team up with healthcare facilities, patients, providers, and manufacturers of medical devices to address patient safety, cybersecurity, privacy, regulatory, and compliance needs. Our experts can help implement controls throughout the medical device product life cycle, including during the design, development, production, distribution, deployment, and maintenance phase.

We pride ourselves on our deep understanding of how software is developed and implemented as a medical device and how embedded applications control physical medical devices. Our medical device experts can help identify and implement all the requirements to successfully acquire a medical device product launch approval 510(k) for Class A, B, and C devices from the FDA. Our focus and passion are to help our clients confront complex medical device technology requirements. We have helped clients prevent compromised device functionality, data loss (medical or personal), data confidentiality, availability, integrity issues, and targeted fraud attacks.

We understand complex medical device cybersecurity regulatory and compliance standards and requirements. Our experts have a wealth of knowledge and experience in being trusted partners in assessing medical device technology risk and control gaps.

We assist clients in understanding and applying changing medical device technology regulations and getting ahead of fast-changing cybersecurity and privacy laws and regulations. We are trusted partners to various digital health, life sciences, biotech, and medical device technology firms.

medical equipment in hospital room

What We Do:
  • Med-Device Technology Risk & Controls Testing
  • Med-Device Cybersecurity Program Audits
  • Med-Device Pre-Market Cybersecurity Requirements
  • Med-Device Post-Market Cybersecurity Requirements
  • Med-Device Manufacturing Plant Cyber Risk Assessments
  • 510(k) Pre-Market Cybersecurity Controls Assessment
  • 510(k) Post-Market Cybersecurity Controls Assessment
  • Med-Device Hardware Threat Models
  • Med-Device Software Threat Models

What We Know:
  • Medical Device Software – SDLC (ISO/IEC 62304) and best-practices
  • Medical Devices – Application of Risk Management (ISO/IEC 14971)
  • FDA – 510(k) Submissions for Medical Devices
  • FDA – Cybersecurity in Medical Devices: Quality System Considerations
  • FDA – Pre-Market Submissions for Management of Cybersecurity in Medical Devices
  • FDA – Pre-Market Submissions for Software Contained in Medical Devices
  • FDA – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
  • FDA – Post-Market Management of Cybersecurity in Medical Devices
  • NIST (SP800 Series, CSF, SP1800 Series)

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