About Us
The Harvest Group, Inc.
Michael Vergano started The Harvest Group in 1998 to provide consulting services to a wide range of medical device industry clients from start-ups to major corporations. Over the past 20+ years Michael has provided his expertise in medical device product development, project management, operations, engineering, quality, and quality system management to clients in the medical device and biotech industries in North America, Europe, Australia, and Asia.
Michael Vergano - Principal
The company's founder, Michael G. Vergano, has 30+ years experience in the medical device and biotech industries. Starting his professional career after earning an engineering degree from Tufts University (BSME), he has been employed at both large corporations and small start-up ventures. Michael has held positions as design engineer, manufacturing engineer, engineering manager, sales territory manager, quality manager, director of operations and product development, inclusive of regulatory and quality responsibilities. Michael's hands-on product experiences range from medical devices including laparoscopic instruments, catheters, balloons, GI endoscopy and electrocautery devices to temperature-controlled packaging design and validation for biologic materials. Sales experience in medical devices has provided a strong sense of customer awareness, as well as medical procedure and market insight. These dynamic experiences provide an essential combination for effective and successful business leadership. Michael is a Certified Biomedical Auditor and is the holder of 13 medical device patents.
Why The Harvest Group?
The Harvest Group is a small consulting entity with an outstanding reputation for customized and personalized service, efficient and effective client communication, and highly skilled expertise in the core competencies of medical device engineering, quality, project management, operations, and product development. Partnerships with well-established medical device consultants permit a highly adaptable consulting team for customization of each client’s projects.
Maintaining up-to-date knowledge of medical device industry regulations and standards is of paramount importance and a top priority. Continual education of updated standards and regulations is constantly pursued.
Services
Providing expertise in product development, project management, operations, engineering, quality, and quality system management to clients in the medical device and biotech industries.
Projects
Recent client projects include:
- Project management of new medical device development through product launch via use of Gantt charts inclusive of over 1500 tracked action items and weekly progress update meetings.
- Establishing a Quality Management System for a medical device manufacturer compliant with FDA, ISO 13485, and MDR requirements.
- Auditing of client QMS (Certified Biomedical Auditor).
- Updating a Quality Management System from the ISO 13485:2012 standard version to the ISO 13485:2016 version inclusive of related quality plans and gap analysis.
- Updating quality systems from the Medical Device Directive (MDD) to the updated Medical Device Regulation (MDR).
- Modifying QMS to be compliant with Medical Device Risk Management standard ISO 14971 and conducting required risk assessment activities.
- Establishing device master validation plans; writing process (IQ/OQ/PQ) and design validation protocols and reports.
- Managing medical device product development efforts through all phases of design control.
- Designing and testing of thermal controlled shippers for biomaterials. Establishing thermal cycle requirements for shippers.
- Planning and overseeing commercialization program of new medical device product launch including sourcing and qualification of contract manufacturing, supply chain, distribution, and servicing efforts.