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Consulting Services

Our consulting services are tailored to your needs. We can help you anywhere from streamlining your quality process to submission and post-market compliance.

We are dedicated to your success

Deliver your product to market with confidence with the help of our dedicated consultants. Bolstered by first-hand experience working in the medical device industry and an acute aptitude for accurately assessing risk, our consultants empathize with the challenges of navigating the product development lifecycle.

Committed to keeping you compliant, our consultants provide guidance throughout the entire regulatory journey—from training your team and implementing custom SOPs to writing your submissions and diligently preparing you for audits. Powered by a team with extensive experience and expertise in FDA and ISO compliance guidelines, Corrective and Preventive Action (CAPA) software, medical device product development, life sciences technology infrastructure, and the nuances of relevant codes from 21 CFR 820 to ISO 13485, Enzyme’s consulting services save time, increase accuracy, and put sustained compliance within reach.

Enzyme is your development, quality, and regulatory partner

Enzyme’s mission is to empower life sciences companies to innovate better and faster
Our experts support life sciences companies in navigating the path of compliance and ensuring program success
We support the development and commercialization of digital, drug-device combination, software/hardware, diagnostic, and disposable healthcare products

Enzyme works with you

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 work globally - Enzyme Consulting integrates with international clients and global teams
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

Development, engineering, and quality services

Design assurance: We ensure proper verification and validation of your product prior to design transfer and submission, reducing risk of rework and project churn
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
Quality and quality systems: Quality systems setup from scratch and optimizing existing systems, assisting with audit preparation and defense, and running remediation projects
Clinical trial design and specialty engineering: Specialty engineering and technical services, software, biomedical & mechanical engineering, and biostatistics    

Regulatory services

Regulatory strategy: From FDA engagement strategies to optimizing system architecture to streamlining approval processes, our regulatory expertise ensures your success  
Submission and engagement: The Enzyme team supports 510K, PMA, & combination product/device constituent for the US market and engagement with notified bodies
History of success: We have managed the regulatory workstream to obtain multiple investigational device exemptions (IDE), multiple 510K clearances, and multiple
drug-device combination product approvals (BLA/NDA)

Leadership with experience

Over 50 years of industry experience in compliance, cybersecurity, and product development, from Class I MDSS to Class III implantables and biopharma.

Enzyme Team
Network
Brian Intoccia
Managing Director
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Credentials

- B.S. Mathematics

Experience

- F/T at Amgen, Medtronic, Boston Scientific

- Consultant to Amgen, Sanofi, Regeneron, Eli Lilly, multiple startups

- 15 years experience

Capabilities

- Design Assurance

- Program Management

- Systems Engineering

- Product Development

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Enzyme Team
Network
Jacob Graham
Principal
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Credentials

- B.S. Engineering

- Master of Business Administration

- Certified Biomedical Auditor

- Regulatory Affairs Certified (US)

Experience

- F/T at Medtronic, Boston Scientific

- Consultant to multiple startups

- 15 years experience

Capabilities

- Quality System Management

- Audit Prep & Defense

- Design Assurance

- Product Development

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Enzyme Team
Network
Jared Seehafer
Principal
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Credentials

- B.S. Computer Science & Biology

- M.S. Biomedical Engineering

- Regulatory Affairs Certified(Device)

Experience

- F/T at Medtronic, St. Jude Medical

- Consultant to Amgen, Medtronic, Eli Lilly, multiple startups

- 14 years experience

Capabilities

- Digital Health

- Regulatory Affairs

- Software Engineering

- Product Development

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Start with Enzyme today
info@enzyme.com or

Services

Our consulting services are tailored to your needs. We can help you anywhere from streamlining your quality process to submission and post-market compliance.

Jared Seehafer, RAC
CEO & Cofounder
Jacob Graham, CBA, RAC
COO & Cofounder
Jared Seehafer
CEO & Cofounder
Jacob Graham
VP QA/RA & Cofounder

Guidance for your entire regulatory and compliance lifecycle

Work with our trusted team of regulatory experts to write your submissions
Our team can help you prepare for audits and make sure you are ready

Quality at your fingertips

Our experts are can help you with all your quality needs such as internal audits and targeted training
We can walk you through the SOP’s and help you integrate them with Enzyme’s QMS

We are dedicated to your success

Our in-house experts have worked with a range of product device classes including SaMD, handled several remediations, conducted audits and successful submission and have led in-house compliance and regulatory teams.
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We are committed to empowering your team and getting your product to market faster.
Start with Enzyme today
info@enzyme.com or