Advocate MedTech Solutions Information

Advocate MedTech Solutions was started by co-founders Arnold Oyola and Jonathan Meltzer to leverage their extensive experience in both medical devices and startups to assist startup companies with Product Development and establishing their Quality Management systems. Together they bring over 39 years of experience (26 at startups) and knowledge working in the medical device and diagnostics fields in Boston. Their backgrounds include working on FDA Class I, Class II, Class III medical and Class I IVD devices. Startups provide the opportunity to bring forward novel, innovative technologies but have the an additional challenge to build the infrastructure and processes needed to quickly mature a new company while not slowing down the engineering development. With a deep understanding that comes from having grown multiple startups, Arnold and Jonathan have chosen to focus on providing consulting in specific areas where leveraging their experiences can provide impactful benefits to reduce implementation times. These areas are: 1. Assisting with establishing their Quality Management Systems. There are numerous processes and SOPs that must be authored and released to create a QMS. Throughout their careers they have authored or assisted in the preparations of dozens of procedures. Some examples include: • Defect Tracking procedure • Design Input procedure • electronic Engineering Change Order Process • Phase Review procedure • Product Realization procedure • Risk Management procedure • Sample size procedure • Unique Device Identifier procedure • Verification procedure 2. Assisting with the following areas of Product development: • Project planning • Requirements definition • Subsystem requirements definition • Traceability • Risk Management • Detailed hardware / software integration planning • Project planning • Verification planning and protocol preparation • Compliance testing