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Consultant Profiles

ADEANA DORSEY is a CRO Group biologic – medical device combination quality system compliance expert.  Adeana has over 10 years experience in this field, leading and managing quality systems according to ISO 13485, ISO 9001, 21 CFR 820, and 21 CFR 211.  As a certified lead auditor, she specializes in establishing and maintaining supplier audit and internal audit processes, and general quality systems for virtual manufacturers.

IRA DUESLER is a CRO Group active and inactive medical device and quality system compliance and regulatory expert.  Ira has over 15 years experience in this field, preparing 510(k) submissions  and international product registrations as well as managing and directing quality systems (ISO 13485, EU-MDD, CMDCAS) activities including management representative, internal audit, CAPA, complaint handling, design and development quality engineering, and document control systems. . 

LEONARD EISNER is the CRO Group's active (electrical safety and EMC) medical device and quality system compliance expert.  Leonard is the principal of Eisner Safety Consultants.  He is a licensed professional engineer in safety engineering. He has 15 years experience in product safety at U.L.,TÜV and Karl Storz Inc. Leonard was the Manager of Compliance Engineering at Karl Storz and Senior Product Safety engineer at TÜV Product Service.

STEPH HUBERT is a CRO Group Quality Systems associate specializing in the upgrading of quality systems with process mapping documentation such as that required for ISO 9001:2000 and ISO 13485:2003, and in the preparation of technical product documentation. 

TIM LENIHAN heads up The CRO Group's European office, and serves as the EU Authorized Representative for many CRO Group clients.  Tim is an American citizen and studied Bioengineering at the University of Pennsylvania as well as Biomedical Engineering at Rensselaer Polytechnic Institute in Troy NY.  His practical experience was gained working at Arrow International, a leading international cardiovascular products company, of Reading, PA, where he was responsible for a variety of areas including product development,  program management for all of Arrow’s therapeutic electrophysiology devices, and research & development as well as manufacturing operations for Arrow in Europe.  He is the founding President of CMI, GmbH, responsible for general management, customer/client satisfaction, and directly manages the firm’s Authorised Representative business for CRO Group, Inc. client companies.

BILL MCLAIN is a CRO Group inactive (non-electrified) medical device and quality system compliance expert.  Bill has over 15 years experience in this field, and has brought dozens of medical device manufacturers through the ISO 9000 / ISO 13485, CE Mark, and CMDCAS certification process.

MARK ROBERTS is the CRO Group's implantable and invasive biocompatibility, packaging, and sterilization expert.  Mark is the principal of Roberts Consulting and Engineering.  He is a certified lead auditor and CE marking and product sterilization expert. He has over 20 years of medical device industry experience. Previously he was the head of western US operations for TÜV Product Service. Prior to that he was Manager of Quality System for Becton Dickinson and Sterility Assurance Manager for Baxter Healthcare, Bentley Division

PHIL SMART is the CRO Group senior consultant.  He is a MDD/IVDD Notified Body/CMDCAS Lead Auditor, a Notified Body/CMDCAS Registrar, Japan PAL Registrar Instructor/Trainer, and heads the CRO Group Corporate Client Instructor/Trainer Program in ISO 9000, ISO 13485, MDD, IVDD, Canadian Medical Device Regulation (CanMDR)/CMDCAS, Japan PAL, ISO 14971, and internal auditing.  

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