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Privacy Program Solutions for MedTech

Manor Associates Team

Manor Associates' team has extensive experience in privacy program design and execution in the medical technology industry. We are fully dedicated to making you - our clients - successful.
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Michael Levinger - Managing Partner

Mike is an accomplished senior executive and entrepreneur with experience in information technology software, services, and hardware businesses. As a senior executive, Mike has led all aspects of compliance including definition of goals, strategies to achieve those goals, and then implementation. He aligns all constituents including client and internal staff, service and consulting firms, and regulatory agencies to address regulatory compliance challenges, Mike has in-depth knowledge of numerous regulatory requirement areas including privacy (CCPA and GDPR), HIPAA, CMS MACRA/MIPS, FDA, MDR, and security. He has extensive program management experience having led complex, multi-function, multi-national teams to achieve compliance goals. Mike is on the faculty of Boston University where he teaches Master's degree computer science courses in health informatics.

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Joe Silvia - Principal

Joe Silvia has extensive experience in regulatory compliance and medical devices especially in software, mobile apps, and security. He has deep knowledge of cybersecurity regulations and standards such as the NIST Framework and FIPS. He has multiple certifications and completed training including in medical device software development and validation, CISSP, Cybersecurity Risk Management, and ISO 27001:2022. Joe is a certified QMS Lead Auditor for ISO 9001:2015 and ISO 13485:2016. Joe combines technical and business acumen to coordinate system reviews and risk assessments with security, development, and operations teams. operational efficiency and compliance.

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Darryl Athans - Principal

Darryl Athans is a seasoned executive with over 25 years in cybersecurity bringing deep expertise in building global, high-growth sales and services delivery organizations across both private and public sectors. Darryl has a proven track record of guiding teams in generating both outstanding customer satisfaction and retention rates and record revenues. He is known for building exceptional levels of collaboration and alignment with clients, his internal team, and vendor partners. Darryl has conducted business in 40+ countries where he is described as entrepreneurial, strategic, and determined. He has been a speaker at industry events and conferences throughout EMEA, MENA, Asia and North America.

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Keshu Nso - Senior Director

Keshu Nso is a quality and regulatory affairs professional. She is an expert in providing strategic regulatory guidance and managing regulatory submissions for the biotech, pharmaceutical, and medical device industries. Keshu is a subject matter expert in quality management systems including premarket, production and postmarket. She has extensive knowledge of medical device classification, regulation, and registration for the US, the EU, Japan, and Canada including FDA regulatory submissions experience in BLAs, CMC INDs, NDAs/ANDAs, 510(k)s, Denovos and PMAs. She is trained/certified auditor in ISO 13485 QMS, EU MDR, and MDSAP and has experience in multiple other audits including of 21 CFR, ISO 14971, and QMS. Keshu has successfully supported regulatory affairs’ life-cycle management activities and provided regulatory guidance to all aspects of a business’ operations.

Kenneth Fuh - Senior Director

Kenneth Fuh PhD - Senior Director

Ken is a highly skilled medical device regulatory consultant specializing in in vitro diagnostics, medical device software, AI/ML-enabled devices, and cybersecurity. With certifications in EU MDR, IVDR, Risk Management, and Medical Device Cybersecurity, he is equipped to assess technical documentation and provide expert guidance on regulatory compliance. Dr. Fuh is also a recognized expert in machine learning, having been invited to speak at prestigious industry events. With a comprehensive understanding of international regulations and direct experience with various standards, he offers valuable insights and support to clients.

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Coco Jaenicke - Director of Marketing

Coco brings extensive experience in marketing of  start-ups and enterprise companies. She leads marketing efforts through periods of startup and significant change. Clients include Red Hat (Dir. PM), IONA/FuseSource (VP mktg), M ortgage Builder (VP mktg), Verivo Software (CMO), Tokutek (VP mktg).

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Jennifer Tierney - Strategic Advisor

Jen is an accomplished privacy and AI governance professional with 10 years experience in the realms of privacy, compliance, governance, risk, and cybersecurity. She is passionate about data subject rights and data ethics. Over the past 12 years, she has worn many hats at the SaaS company Brandwatch. She is also a member and volunteer at the IAPP and currently serves as co-chair for their Boston area KnowledgeNet chapter. Jen specializes in building relationships and collaborative partnerships across organizations and socializing regulatory changes among various stakeholders. She has a Master's degree in Library and Information Sciences and is often mistaken for a lawyer. 

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