Our Team

mcox

Contact Info:
Email: mcox@alvamed.com
Office: (781) 710 – 2418

Mark Cox, President and Founder:

Mark Cox has 20 years of experience helping clients throughout North America and Europe value technologies, and develop and introduce new medical products. His expertise includes due diligence management, technology transfer and licensing, IP valuation and strategy, and product cost analysis. Mark has led or contributed his expertise to more than 20 due diligence efforts, and his cost-analyses and opportunity identification efforts have saved clients as much as $10 million annually on a single product line.

Mark founded AlvaMed in 2003 to provide consultation services to medical device companies throughout the product lifecycle. Before founding AlvaMed, Mark spent 16 years as a consultant, most of which were with Arthur D. Little.

Mark holds a BE in Metallurgy and Materials Science from Imperial College, London, and an MS in Materials Engineering from MIT.


 

jsaltonstall

Contact Info:
Email: jsaltonstall@alvamed.com
Office: (781) 710 – 2418

Jon Saltonstall, Vice President:

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.


 

kbeckett

Contact Info:
Email: kbeckett@alvamed.com
Office: (781) 710 – 2418

Kerry Beckett, Clinical and Quality Affairs Manager:

Kerry Beckett has more than 7 years of experience managing and supporting clinical research, regulatory and quality assurance projects. Kerry held a senior level specialist role in clinical, regulatory and quality affairs prior to joining AlvaMed. She has experience conducting clinical monitoring – both remotely and at the site level. She also designs, implements, and maintains clinical data management systems. Kerry has expertise in building and managing clinical trial master files and clinical document creation. She also has experience designing, populating and managing ISO 13485 compliant Quality Management Systems for startup medical device companies. Kerry is experienced in supporting 510(k) and IDE regulatory submissions.

Kerry’s qualifications include the following:

Clinical Affairs

  • Created and managed Clinical Trial Master Files for clients.
  • Developed and updated clinical documents such as procedures, clinical protocols, investigator brochures, monitoring plans, case report forms, and study logs.
  • Created clinical analysis reports, clinical event reports, and conducted clinical literature reviews.
  • Qualified clinical sites and conducted site and remote monitoring of study data.
  • Created and maintained multiple clinical databases (both manual and EDC).

Quality Management Systems

  • Created, populated, and maintained ISO 13485 compliant quality management systems and successfully achieved ISO certification for those clients.
  • Developed and updated procedures to comply with ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
  • onducted quality audits in accordance to ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
  • Performed document control for ISO 13485 compliant quality management systems.

Regulatory Affairs

  • Supported 510(k) and IDE writing and submission.
  • Supported the drafting and submitting of technical bulletins.
  • Supported Ethics Committee submissions for Clinical Trials.

Kerry holds a Bachelor of Science in Nutrition from Texas State University and is certified by the Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional (CCRP®).


 

Contact Info:
Email: mhooper@alvamed.com
Office: (781) 710 – 2418

Melissa Hooper, Quality System Associate:

Melissa Hooper has 2 years of experience managing and supporting regulatory and quality assurance projects. She has experience designing, populating, and maintaining ISO 13485 Quality Management Systems for startup medical device companies. Melissa is practiced in supporting 510(k) regulatory submissions.

Melissa’s qualifications include the following:

Quality Management Systems

  • Created, populated, and maintained ISO 13485 Quality Management Systems and successfully achieved ISO certification, as well as CE Mark and FDA device approvals, for those clients.
  • Developed and updated procedures to comply with ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOP/98-282, and CMDCAS standards.
  • Conducted quality audits in accordance to ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282, and CMDCAS standards.
  • Performed document control for ISO 13485 Quality Management Systems

Quality Management Systems

  • Created, populated, and maintained ISO 13485 compliant quality management systems and successfully achieved ISO certification for those clients.
  • Developed and updated procedures to comply with ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
  • onducted quality audits in accordance to ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
  • Performed document control for ISO 13485 compliant quality management systems.

Regulatory Affairs

  • Supported 510(k) writing and submissions.
  • Supported the drafting and submissions of technical bulletins.

Melissa holds a BS in Earth and Space Sciences with an Emphasis in Biology from the University of Washington.


 

Diana

Contact Info:
Email: dgrenier@alvamed.com
Office: (781) 710 – 2418

Diana Grenier, Senior Consultant:

Diana Grenier has 18 years of experience in project and quality engineering, primarily in the design, qualification and manufacture of medical devices (guidewires, urological devices, and intravenous delivery systems).

She is proficient in the areas of: product, process, and test method validation; failure analysis, including complaint investigation; and auditing, including compliance to Quality System Regulations ISO 13485 and 21 CFR Part 820.

As a Quality Engineering Consultant, Diana has helped engineering, manufacturing and quality departments improve the quality and reliability of new and existing products, including:

  • Review and approval of operating procedures, process validations (IQ, OQ, PQ) and Design Change Orders.
  • Analyzing quality information and reviewing recommendations for adjustments to product designs, manufacturing processes, equipment and the quality system.
  • Coordinating responses to observations, including implementation of CAPA plans resulting from customer audits and/or notified body inspections.
  • Supporting validation of manufacturing processes transferred to facilities in the United States and Mexico.

As a Quality Engineering Manager and Principal Design Engineer, Diana has:

  • Managed complaint, NCMR, CAPA, calibration systems (including failure analysis, trending and reporting), and a Reliability Test Laboratory – where she coordinated testing priorities and ensured completeness and accuracy of test data.
  • Reviewed and approved test procedures and reports for design and manufacturing engineering groups.
  • Assessed alignment between Quality objectives and goals, product specifications, drawings and test procedures.
  • Managed the conversion of the sterilization process for disposable medical devices from EtO to radiation sterilization. She coordinated the activities of product, quality and sterilization engineering, including functional qualifications, biocompatibility testing and bioburden/subdose evaluations. In addition, she performed the qualification and phase-in of material changes required for the implementation of the sterilization conversion.

Diana received her BS in mechanical engineering, with a minor in management, from Tufts University, College of Engineering. She received her ASQ Certified Quality Engineer (CQE) (active through 2009) and held a Professional Engineer (PE) license in mechanical engineering from the NC Board of Engineers and Land Surveyors (active through 2008).


 

Roberta

Contact Info:
Email: rhines@alvamed.com
rhines Office: (781) 710 – 2418

Roberta Hines, Senior Advisor:

Roberta Hines has 30 years of senior level experience as a successful regulatory professional in the medical device industry. 

Roberta brings a unique blend of expertise in regulatory affairs, quality assurance and clinical research in Class I, II and III devices including a wide variety of medical devices:

  • surgical and percutaneous cardiovascular implants;
  • implantable orthopedic devices;
  • neurovascular implants;
  • interventional cardiology and endovascular devices;
  • combination drug/device products;
  • diagnostic cardiovascular devices;
  • ventilators;
  • peripheral staple and atherectomy devices;
  • various ancillary accessories; and,
  • medical equipment including software and hardware driven devices.

With her experience in strategic regulatory and clinical research planning, Roberta guides companies in bringing their products from concept through global market introduction in the fastest time possible.  Additionally, Roberta is an expert in the design and development of Quality Management Systems and has implemented these systems for many companies. 


 

Eric

Contact Info:
Email: ebannon@alvamed.com

Eric Bannon, Senior Consultant:

Eric Bannon, senior consultant, has over 30 years of experience providing clinical and regulatory support for medical device companies. His expertise focuses on implementing creative regulatory and clinical strategies from development through commercialization with experience in multiple therapeutic areas including Endoscopy, Orthopedics and Gastroenterology and Metabolic Diseases.

Clinical Strategy and Implementation

  • Built a clinical operations team to support execution of 350 patient trial including CRO management, case support and recruitment to goals
  • Successful completion of OUS first in human trials to support procedural development efforts and establish acceptable safety profile
  • Integration of CMS recommended reimbursement measures into spinal stenosis trial that led to significant coverage of trial execution costs
  • Coordination of multiple clinical programs to support type 2 diabetes indication in the US and EU

Regulatory Achievements

  • Coordinated and led the successful approval of IDEs for hydrothermal ablation catheter for Type 2 Diabetes, suture fixation device for reflux disease and metallic implant to treat spinal stenosis.
  • Developed and executed successful strategies that led to early CE Mark approvals for class II and III devices in the EU
  • Successfully navigated worldwide approvals for initiation of pre and post-market clinical trials in US, EU, Canada and South America
  • Coordinated multinational commercialization effort for broad line of sports medicine devices in EU, Japan, Canada and Korea

Eric received his BS in microbiology from the University of Maine at Orono.