JWM Associates LLC is a professional consulting company specializing in consultation for biomedical companies in the areas of Quality Systems regulations to FDA and ISO 13485 and 9001 standards, medical device regulatory submission preparation and assistance, validation protocol development, in-vitro diagnostics consultation, project management, production and QC document development, and Laboratory facilities planning.
Developing and maintaining medical products in the market is a complex and challenging task. At every step in the process, there is the potential that the regulatory requirements will become barriers to the marketplace. We are available to help. Our services are customized to each client's needs and expectations. We are available on a per diem, project or retainer basis.
Jeff Morgan, Principal Consultant for JWM Associates LLC, has over 30 years of combined Medical and Industrial experience. His expertise includes Quality Systems (FDA QSR, ISO 9001 and ISO 13485) consulting and auditing, having formal ANSI-RAB Accredited Lead Auditor training. Jeff has also provided consultation in the areas of Compliance audits, procedure development and technical writing, management of technology transfer and scale-up, validation methods and protocol development, and ELISA research and development.
For additional information, call 253.208.3430 or e mail to: jm @ jwmabio.com (note: This is not a direct e-mail link to cut down on spam bots)
Biomedical and Clinical Consulting