RAMP Consultants

Elaine Penta Rampone Elaine Penta Rampone has been the owner and Chief Executive Manager of RAMP Enterprises, LLC since 1996. Elaine has over 20 years experience in project engineering and quality assurance management. She has a Bachelor of Science in Mechanical Engineering, with a minor concentration in Biology, from Northeastern University (1989) and a Masters of Science in Industrial Engineering from the University of New Haven (1992). Prior to RAMP, Elaine worked for General Dynamics, Electric Boat Division and a series of small family-owned businesses, with positions in Project and Design Engineering, Quality Procurement Engineering, and Quality Management. Through RAMP, Elaine has assisted over a 100 companies through the quality management implementation process for the following standards: ISO 9001 (Commercial Industry) ISO 13485 (Medical Industry) FDA QSR (Medical Industry) AS 9100 (Aerospace Industry) TS 16949 (Automotive Industry) QS 9000 (Automotive Industry) Various Military Standards (Government) Elaine has been accredited with the QSARAB as a certified associate auditor for over 10 years (Q06691) and has been a member of the American Society of Quality for over 15 years. Elaine has been an accredited Certified Quality Auditor through the ASQ. RAMP has a 99% success rate with bringing clients through successful registration and permanent continued success.

	Joseph Azary Joseph Azary is an ASQ Certified Quality Auditor (CQA); is Regulatory Affairs Certified (RAC), and has passed the RAB Lead Assessor testing requirements. Joseph has a bachelor’s degree in Biological Sciences and a Masters Degree in Business Administration. He has over 17 years experience in regulated industry, most of which was in the medical device industry. He has been employed by large Fortune 500 companies (such as U.S. Surgical Corporation, Johnson & Johnson) as well as Multinational companies (Fuji Photo Film – Fujifilm Medical division). Additionally, Joseph has worked with over 130 small-medium sized medical device companies performing activities ranging from auditing, training, quality system development including ISO 13485, ISO 9001, and FDA QSR, regulatory compliance, international regulations (including European MDD – CE Marking, Canadian Medical Device Regulations, Japanese Medical Device Regulations), and regulatory submissions (including 510k’s and PMA’s). Joseph has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations.

John Chapman John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. RAB Accredited Lead Auditor Course Certificate1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference. John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory subjects.

	Joseph DeCarlo Joe has over 20 years of experience as a business management consultant, instructor and senior level professional. He has in depth knowledge and extensive experience working in general manufacturing, aerospace, automotive and medical/pharmaceutical industries. His past positions include Vice President of SAI Global, a multinational consulting firm and Division Manager at TUV Rheinland, a testing and third party certification organization. In addition, he has worked to implement hundreds of management systems in organizations ranging from small to mid-sized firms to mutli-national corporations and has trained over 5000 people in all aspects of Management systems. His past clients include: Swagelok Corporation, PRA International, DamilerChrysler, NorthrupGrumman, Lockheed Martin, Boeing, Schick and BMW of North America. He is a frequent lecturer on different topics of Management Systems and has presented at Harvard University – School of Public Health, Columbia University, Fordham University and Central Connecticut State University. In addition he is a past chair of the Danbury ASQ and an RAB-QSA Registered Lead Assessor. He lives in Connecticut with his wife and 2 children and is a trained Wish Granter and volunteer for the MakeAWish foundation of Connecticut.