Jon Saltonstall is Vice President of Regulatory and Quality Compliance at AlvaMed. Jon has more than 20 years of experience developing Class II and Class III cardiovascular catheters, disposables and implants. Jon has held quality assurance leadership roles in several startup companies from pre-clinical to early stage commercial. He has expertise in quality system design and implementation as well as design controls, risk management and manufacturing transfer. Jon also has experience working in contract R&D and manufacturing environments. Jon is a detail oriented problem solver capable of working independently or as part of large cross functional teams.

Jon’s accomplishments include the following:

Quality Systems

  • Installed and maintained nimble FDA/ISO/MDD/CMDR compliant quality systems at three startups that led to FDA device approvals, OUS clinical trial approvals and CE Mark approvals.
  • Developed procedures that embrace a common sense approach to quality: balancing compliance and flexibility. This allows companies to move rapidly through the development process, while producing high quality products and documentation.
  • Experienced internal auditor and external audit host/coordinator with long history of successful federal, state and Notified Body audits.
  • Performed CAPA investigation, root cause analysis, resolution, and effectiveness checks.
  • Performed complaint investigation, MDR and vigilance reporting.

Design and Manufacturing

  • Served as Acting Head of QA (including Management Representative) on behalf of virtual companies, including oversight of contract design/manufacturers.
  • Developed product specifications and corresponding design verification methods for mechanical devices, catheters and implants.
  • Led risk management activities in compliance with ISO 14971 including hazard analysis, design and process FMEA, post production risk management activities.
  • Designed and executed strategies for biocompatibility testing, ethylene oxide and gamma sterilization validation, packaging/transit validation, aging validation.
  • Performed equipment IQ/OQ/PQ, calibration, maintenance and monitoring.
  • Performed production QA activities such as inspection and sampling plans, training, batch records, and scale up.

Regulatory Affairs

  • 510(k) and IDE writing and submission.
  • Writing of technical documentation that resulted in CE Mark approval and Canadian Medical Device Licensing.
  • Author of clinical trial application and investigator’s brochure to support approval of OUS clinical trials.

Jon holds a Bachelor of Science in Mechanical Engineering from Northeastern University.

Contact Info:
Office: (888) 33 – 13485 Ext. 1