CONSULTINGIn-house experts
at the ready
Our in-house support team, each with 10+ years of experience, is here to help – from day-to-day support to acting as your consultant to FDA, notified bodies, and other stakeholders.
Your success is our success
Enzyme offers three levels of support depending on your goals and needs.
Enzyme Support
Included as part of your onboarding and training, our Customer Success team will teach you how to use your new Enzyme eQMS over the course of three one-hour sessions.
Enzyme Enhance
Receive continuing access to our Customer Success team for expert advice anytime you need it — from optimizing your eQMS to helping you develop and market your product.
Enzyme Consulting
Need a consultant to write a submission, assist in an audit, or represent you to FDA or notified bodies? Unique amongst eQMS vendors, Enzyme’s consulting team can take you from product inception through regulatory approval.
Enzyme works with you
We support the development and commercialization of digital, drug-device combination, software/hardware, diagnostic, and disposable healthcare products.
We can integrate with your team or work independently and autonomously
We offer flexible work packages to address your needs, from time-and-materials, to project-based, retainer, or embedded resource
We understand the needs of companies of all sizes, from 2-person startups to Fortune 500 enterprises, and we understand how those needs differ
We provide service to clients inside or outside the Enzyme eQMS — our team are experts at navigating complex and diverse quality systems
OUR AREAS OF EXPERTISEDevelopment, engineering, and quality services
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Design assurance
We ensure proper verification and validation of your product prior to design transfer and submission, reducing risk of rework and project churn
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Systems engineering
We have adapted the key principles of systems engineering to the regulated medical environment, enabling high-quality design control and risk management deliverables, specializing in SaMD, combination, and disposable devices
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Quality and quality systems
We set up quality systems from scratch and optimize existing systems, assist with audit preparation and defense, and run remediation projects
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Clinical trial design and specialty engineering
We offer clinical and technical services, software, biomedical & mechanical engineering, and biostatistics
Regulatory services
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Regulatory strategy
From FDA engagement strategies to optimizing system architecture to streamlining approval processes, our regulatory expertise ensures your success
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Submission and engagement
Enzyme supports 510(k), PMA, and combination product/device constituents for the U.S. market and engagement with notified bodies
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History of success
We have managed the regulatory workstream to obtain multiple investigational device exemptions (IDE), multiple 510(k) clearances, and multiple drug-device combination product approvals (BLA/NDA)
Meet our consultants
Our team has extensive experience and expertise in FDA and ISO compliance guidelines, CAPA software, medical device product development, life sciences technology infrastructure, and the nuances of relevant codes from 21 CFR 820 to ISO 13485.
- Jared Seehafer
- Jacob Graham
- Brian Intoccia
- Michelle Rubin-Onur, PhD
- Michelle Avila
- Todd Etzel
Jared is a 15-year veteran of the medical device and biopharma industries, with a background in product management, digital health, and regulatory strategy. His experience includes leading spinal cord stimulator programs at St. Jude Neuromodulation (now Abbott), the UI/UX for the first hybrid closed loop insulin pump at Medtronic Diabetes, and the regulatory strategy and submissions for numerous combination drug-device products, including Amgen’s Neulasta Onpro and Repatha Pushtronex. Since co-founding Enzyme, he has represented over two dozen companies in interactions with FDA and equivalent regulatory bodies. Jared has an MS in Medical Device Engineering from USC, a BA in Molecular Biology, and a RAPS Regulatory Affairs Certification (RAC).
Co-Founded Enzyme 2017
Areas of expertise
- Regulatory strategy & submissions
- Digital health
- Regulated software development
- Product management
Jacob has 15+ years of experience in the medical device industry. His background includes R&D new product development and sustaining engineering, design assurance engineering, extended quality team management, overall quality system ownership and implementation, and audits. He has helped commercially launch and maintain several Class II and III devices and has overseen multiple FDA and EU notified body, supplier, and internal audits. Prior to co-founding Enzyme, he held quality management positions at Medtronic and Boston Scientific. Jacob has an MBA from Babson College and a BS in Engineering from Olin College. He is an ASQ Certified Biomedical Auditor and is RAPS Regulatory Affairs Certified (RAC).
Co-Founded Enzyme 2017
Areas of expertise
- External, internal, and supplier auditing (ISO 13485, 21 CFR 820; CA FDB, FDA, Notified Bodies, Registrars)
- Quality system design, assessment, changes, and implementation
- Design assurance (traditional/physical Class II & III devices): product development, specification setting, risk management, test method validation, process validation (IQ/OQ/PQ, statistical analyses)
- Management review, training, CAPA, NC, market withdrawals
- Sterilization (E-Beam, EtO) and biocompatibility
- Materials/supplier qualification
Brian has 15 years of experience working in the medical device and biopharma industry, with a background in medical device product development process, design assurance, and systems engineering. He has been responsible for successfully launching Class II & III devices and drug-device combination products at major companies like Amgen, Medtronic, and Boston Scientific. Prior to joining Enzyme he was a consultant to the biopharma industry, including clients like Amgen, Sanofi, Regeneron, and Eli Lilly.
Joined Enzyme 2020
Areas of expertise
- Quality assurance
- Program development
- Team development
- SaMD, capital equipment, disposables, combination products
Michelle has authored and led numerous premarket submissions and regulatory strategies for Class I-III devices, including radiation therapy systems, implantable markers, surgical instruments, nerve stimulators, in-vitro diagnostics, SaMD, and powered wheelchairs. She holds a PhD in Biomedical Sciences from Baylor College of Medicine.
Joined Enzyme 2023
Areas of expertise
- Regulatory strategies and submissions
- Digital health
- Traditional medical devices
- Product management
- Quality systems
A Quality Manager with 8 years of experience in the medical device industry, Michelle has a background in post-market processes and quality systems implementation. In addition to her work in Enzyme Professional Services, she engages with Enzyme customers on an ongoing basis through her work in Enzyme Customer Success.
Joined Enzyme 2021
Areas of expertise
- QMS implementation
- Postmarket QMS
- Optimizing use of Enzyme software
Todd is a software developer and maintenance engineer with 20 years of experience in web app and infrastructure management. He brings a unique perspective to client projects, informed by his experience in both mainstream software and SaMD development and quality management.
Joined Enzyme 2020
Areas of expertise
- Software development lifecycle for SaMD/SiMD/GxP systems
- Cybersecurity documentation and threat modeling
- Software quality assurance and test automation
- Enzyme integrations
Jared Seehafer
Jared is a 15-year veteran of the medical device and biopharma industries, with a background in product management, digital health, and regulatory strategy. His experience includes leading spinal cord stimulator programs at St. Jude Neuromodulation (now Abbott), the UI/UX for the first hybrid closed loop insulin pump at Medtronic Diabetes, and the regulatory strategy and submissions for numerous combination drug-device products, including Amgen’s Neulasta Onpro and Repatha Pushtronex. Since co-founding Enzyme, he has represented over two dozen companies in interactions with FDA and equivalent regulatory bodies. Jared has an MS in Medical Device Engineering from USC, a BA in Molecular Biology, and a RAPS Regulatory Affairs Certification (RAC).
Joined Enzyme 2017
Areas of expertise
- Regulatory strategy & submissions
- Digital health
- Regulated software development
- Product management
Jacob Graham
Jacob has 15+ years of experience in the medical device industry. His background includes R&D new product development and sustaining engineering, design assurance engineering, extended quality team management, overall quality system ownership and implementation, and audits. He has helped commercially launch and maintain several Class II and III devices and has overseen multiple FDA and EU notified body, supplier, and internal audits. Prior to co-founding Enzyme, he held quality management positions at Medtronic and Boston Scientific. Jacob has an MBA from Babson College and a BS in Engineering from Olin College. He is an ASQ Certified Biomedical Auditor and is RAPS Regulatory Affairs Certified (RAC).
Joined Enzyme 2017
Areas of expertise
- External, internal, and supplier auditing (ISO 13485, 21 CFR 820; CA FDB, FDA, Notified Bodies, Registrars)
- Quality system design, assessment, changes, and implementation
- Design assurance (traditional/physical Class II & III devices): product development, specification setting, risk management, test method validation, process validation (IQ/OQ/PQ, statistical analyses)
- Management review, training, CAPA, NC, market withdrawals
- Sterilization (E-Beam, EtO) and biocompatibility
- Materials/supplier qualification
Brian Intoccia
Brian has 15 years of experience working in the medical device and biopharma industry, with a background in medical device product development process, design assurance, and systems engineering. He has been responsible for successfully launching Class II & III devices and drug-device combination products at major companies like Amgen, Medtronic, and Boston Scientific. Prior to joining Enzyme he was a consultant to the biopharma industry, including clients like Amgen, Sanofi, Regeneron, and Eli Lilly.
Joined Enzyme 2020
Areas of expertise
- Design assurance
- Program management
- Systems engineering
- Product development
Michelle Rubin-Onur, PhD
Michelle has authored and led numerous premarket submissions and regulatory strategies for Class I-III devices, including radiation therapy systems, implantable markers, surgical instruments, nerve stimulators, in-vitro diagnostics, SaMD, and powered wheelchairs. She holds a PhD in Biomedical Sciences from Baylor College of Medicine.
Joined Enzyme 2023
Areas of expertise
- Regulatory strategies and submissions
- Digital health
- Traditional medical devices
- Product management
- Quality systems
Michelle Avila
A Quality Manager with 8 years of experience in the medical device industry, Michelle has a background in post-market processes and quality systems implementation. In addition to her work in Enzyme Professional Services, she engages with Enzyme customers on an ongoing basis through her work in Enzyme Customer Success.
Joined Enzyme 2021
Areas of expertise
- Implementation of QMS
- Postmarket QMS
- Overall use of the Enzyme software
Todd Etzel
Todd is a software developer and maintenance engineer with 20 years of experience in web app and infrastructure management. He brings a unique perspective to client projects, informed by his experience in both mainstream software and SaMD development and quality management.
Joined Enzyme 2020
Areas of expertise
- SaMD/SiMD
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
