About Us
We offer consulting services for all aspects of compliance for medical device manufacturing and marketing, as outlined on our Services page. As the complexity is always changing and subject to regulatory interpretation, we will ensure the best advice and service to achieve your objectives.
Christine Cook, President & CEO, is our lead consultant. Christine has worked in the medical device industry for 31 years. This includes hands on experience with mid to senior level management positions in Supply Chain, Manufacturing, Engineering, Quality & Regulatory and General Management for both OEMs and contract manufacturing companies. The technologies cover a broad spectrum of products, from disposables to long term active medical devices. Christine’s approach has always been hands on, with a strong emphasis for engaging with all business partners and internal staff, with integrity and responsiveness.
Chris Higbee, Business Director, provides technical consulting services in Quality Management Systems with a strong emphasis in Supply Chain Management, Regulatory Compliance, Production / Validations, Management Commitment, and Internal Auditing for the Medical Device Industry. Chris has over 11 years of experience in quality management systems, ERP systems and highly regulated manufacturing work environments. Chris has experience in the management of facility relocations, new facility start-ups, ERP systems implementations, offshoring of manufacturing, and international device registrations.
Hannah Foley, QA/RA Consultant provides technical consulting services in Quality Management Systems as well as Research and Development projects with a strong emphasis in project management, design controls, requirements management, design verification/validation, localization, systems integration, and testing/development for the Medical Device Industry. Hannah has experience in new product development, change management, eQMS systems, internal auditing, and working with start-up organizationss. Hannah brings experience across all aspects of the product lifecycle.
Terry Kim, Engineering/RA Consultant, provides technical consulting services in Quality Management Systems with a strong emphasis in device Research and Development, Design Verification / Validation, Technical Documents, Regulatory Compliance, and Internal Auditing for medical device companies. Terry brings interdisciplinary background in biomedical engineering, product development, quality management system, and regulatory strategies. He has helped develop and successfully register numerous medical devices such as dental wound dressing and orthopedic bone grafts. He has helped implement robust quality management system and led FDA 510 k submissions for a wide range of biomaterial products, while also overseeing R&D. The industries served included: Orthopedics / Trauma / Sports Medicine / Spine / Dentistry / Wound Care, and others.
External Resources
Babacar Diouf is an independent contractor, providing technical consulting services for every aspect of Medical Device Regulatory Compliance. Babacar has over 25 years of Engineering and over 17 years’ experience in the entire lifecycle of medical devices with emphasis in Quality Systems and Regulatory compliance, including significant knowledge and technical writing skills in the areas of: Regulatory Planning, Design Control Activities, Risk Management, Biocompatibility, Usability Engineering, Sterilization (Gamma, EO, E-BEAM), PMS / PMCF, Process Validation, Cleanroom Validation, and Clinical Evaluations. His experience includes 15+ years’ overseeing Quality and Regulatory in manufacturing operations for medium to high risk medical devices, covering numerous medical technologies (active and non-active devices). Babacar has a Master’s Degree in Executive Leadership and Organizational Changes and an Engineering Degree in Geosciences.
Marjorie Nelson provides technical consulting services in highly technical operations environments with stringent regulatory requirements. Significant experience spanning strategic and operational environments such as product & process development, QMS implementation, stability plans and protocols for pharmaceutical development, 510K and NDA submission planning and execution, CMC writing and reviewing, manufacturing systems methodologies, New product introduction (NPI), Acquisition transition, Facility transfer & commission, and Supply Chain Management. Marjorie has been a key team member in the commercial launch of multiple innovative medical devices and led the development effort and ultimate commercial launch of a combination drug delivery device.
Nathaniel Skinner is an independent and detail-oriented technical lead of medical device development and commercialization. He is driven to apply his holistic experience in R&D, quality, and regulatory to provide technical consulting services across a wide array of technologies and business models. Past experiences include initial R&D for a total shoulder resulting in an IP license and development agreement and sale, supplier quality auditing, design, deployment, and defense of custom Quality Management System software, as well as the creation of data-driven statistical & analytical models and simulations for device design and quality.
Suzy Sundling provides Biomedical Engineering / QA/RA / Technical consulting with a key strength in regulatory compliance for technical documentation. Suzy has over 12 years of experience in medical device design and manufacturing in operational, quality, regulatory, and engineering roles. She has worked in many different environments and has experience with complex sterile and non-sterile medical devices, working with OEMs and contract manufacturers, and providing consulting services to numerous clients. Suzy has very strong skills in standards reviews, writing technical documentation, manufacturing process capability, design controls, and QMS skills with complaint investigations, CAPA and other critical requirements. Suzy enjoys working remotely with clients, providing detailed and timely deliverables, and is excellent at training the clients as she completes assignments.
Please contact us with your inquiries and needs.
Christine Cook, President & CEO, is our lead consultant. Christine has worked in the medical device industry for 31 years. This includes hands on experience with mid to senior level management positions in Supply Chain, Manufacturing, Engineering, Quality & Regulatory and General Management for both OEMs and contract manufacturing companies. The technologies cover a broad spectrum of products, from disposables to long term active medical devices. Christine’s approach has always been hands on, with a strong emphasis for engaging with all business partners and internal staff, with integrity and responsiveness.
Chris Higbee, Business Director, provides technical consulting services in Quality Management Systems with a strong emphasis in Supply Chain Management, Regulatory Compliance, Production / Validations, Management Commitment, and Internal Auditing for the Medical Device Industry. Chris has over 11 years of experience in quality management systems, ERP systems and highly regulated manufacturing work environments. Chris has experience in the management of facility relocations, new facility start-ups, ERP systems implementations, offshoring of manufacturing, and international device registrations.
Hannah Foley, QA/RA Consultant provides technical consulting services in Quality Management Systems as well as Research and Development projects with a strong emphasis in project management, design controls, requirements management, design verification/validation, localization, systems integration, and testing/development for the Medical Device Industry. Hannah has experience in new product development, change management, eQMS systems, internal auditing, and working with start-up organizationss. Hannah brings experience across all aspects of the product lifecycle.
Terry Kim, Engineering/RA Consultant, provides technical consulting services in Quality Management Systems with a strong emphasis in device Research and Development, Design Verification / Validation, Technical Documents, Regulatory Compliance, and Internal Auditing for medical device companies. Terry brings interdisciplinary background in biomedical engineering, product development, quality management system, and regulatory strategies. He has helped develop and successfully register numerous medical devices such as dental wound dressing and orthopedic bone grafts. He has helped implement robust quality management system and led FDA 510 k submissions for a wide range of biomaterial products, while also overseeing R&D. The industries served included: Orthopedics / Trauma / Sports Medicine / Spine / Dentistry / Wound Care, and others.
External Resources
Babacar Diouf is an independent contractor, providing technical consulting services for every aspect of Medical Device Regulatory Compliance. Babacar has over 25 years of Engineering and over 17 years’ experience in the entire lifecycle of medical devices with emphasis in Quality Systems and Regulatory compliance, including significant knowledge and technical writing skills in the areas of: Regulatory Planning, Design Control Activities, Risk Management, Biocompatibility, Usability Engineering, Sterilization (Gamma, EO, E-BEAM), PMS / PMCF, Process Validation, Cleanroom Validation, and Clinical Evaluations. His experience includes 15+ years’ overseeing Quality and Regulatory in manufacturing operations for medium to high risk medical devices, covering numerous medical technologies (active and non-active devices). Babacar has a Master’s Degree in Executive Leadership and Organizational Changes and an Engineering Degree in Geosciences.
Marjorie Nelson provides technical consulting services in highly technical operations environments with stringent regulatory requirements. Significant experience spanning strategic and operational environments such as product & process development, QMS implementation, stability plans and protocols for pharmaceutical development, 510K and NDA submission planning and execution, CMC writing and reviewing, manufacturing systems methodologies, New product introduction (NPI), Acquisition transition, Facility transfer & commission, and Supply Chain Management. Marjorie has been a key team member in the commercial launch of multiple innovative medical devices and led the development effort and ultimate commercial launch of a combination drug delivery device.
Nathaniel Skinner is an independent and detail-oriented technical lead of medical device development and commercialization. He is driven to apply his holistic experience in R&D, quality, and regulatory to provide technical consulting services across a wide array of technologies and business models. Past experiences include initial R&D for a total shoulder resulting in an IP license and development agreement and sale, supplier quality auditing, design, deployment, and defense of custom Quality Management System software, as well as the creation of data-driven statistical & analytical models and simulations for device design and quality.
Suzy Sundling provides Biomedical Engineering / QA/RA / Technical consulting with a key strength in regulatory compliance for technical documentation. Suzy has over 12 years of experience in medical device design and manufacturing in operational, quality, regulatory, and engineering roles. She has worked in many different environments and has experience with complex sterile and non-sterile medical devices, working with OEMs and contract manufacturers, and providing consulting services to numerous clients. Suzy has very strong skills in standards reviews, writing technical documentation, manufacturing process capability, design controls, and QMS skills with complaint investigations, CAPA and other critical requirements. Suzy enjoys working remotely with clients, providing detailed and timely deliverables, and is excellent at training the clients as she completes assignments.
Please contact us with your inquiries and needs.