Medical Device Consulting Experts

Our experts have a wealth of knowledge and experience in complex medical device regulatory and compliance standards and requirements. 

Advancements in the healthcare industry have increased the use of 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 health care facilities, patients, providers, and manufacturers of medical devices to address human factors, 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 needed to successfully acquire a medical device product launch approval for Class A, B, and C devices from the FDA. Our focus and passion are to help our clients confront the complex medical device technology requirements to prevent compromised device functionality, data loss (medical or personal), data availability or integrity issues, or targeted fraud attacks.

We understand complex medical device 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 Software Requirements Analysis
  • Patient Safety Risk Assessments & Event Reviews
  • UI Design & Evaluation
  • Med-Device Architecture & Design Advisory
  • Med-Device Integration & System Testing
  • Med-Device Pre and Post Software Release Consulting
  • Med-Device Technology Risk & Controls Testing
  • Med-Device Cybersecurity Program Audits
  • Med-Device Pre-Market & Post-Market Cybersecurity Requirements
  • Med-Device Manufacturing Plant Cyber Risk Assessments
  • Med-Device Manufacturing Plant IT & OT Audits
What We Know:
  • Medical Device Software – SDLC (ISO/IEC 62304) and best-practices
  • Medical Devices – Quality Management Systems Requirements (ISO/IEC 13485)
  • Medical Devices – Application of Risk Management (ISO/IEC 14971)
  • FDA – 510(k) Submissions for Medical Devices
  • FDA – Premarket Approval Applications (PMAs)
  • FDA – Product Development Protocols (PDPs)
  • FDA – Investigational Device Exemption (IDE)
  • FDA – Pre-Market Submissions for Management of Cybersecurity in Medical Devices
  • FDA – Post-Market Management of Cybersecurity in Medical Devices
  • FDA – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
  • NIST (SP800 Series, CSF, SP1800 Series)

 

Speak with a Medical Device Expert today