WELCOME TO FISSION CONSULTING SERVICES

Your trusted partner in Quality Management and Regulatory affairs support tailored specifically for the Medical Device Industry.

With over two decades of combined expertise, we’ve solidified our position as industry leaders in medical device consulting, compliance and quality management systems development, and engineering for startups and small businesses, boasting a track record that speaks volumes.

Get Started

ELEVATING EXPERTISE

Our distinctive consultative expertise sets us apart in the realm of SaMD consulting

We’re not just consultants—we’re your dedicated partners committed to empowering your organization with robust quality assurance, development support, and regulatory solutions.

Trust us to guide conversations with regulators, craft development plans, and seamlessly execute on your initiatives. We work as an extension of your team, integrating with your operations to provide customized solutions and support.

With extensive audit experience, regulatory strategy and submissions guidance, DHF remediation expertise, and product development consulting, we offer comprehensive solutions to propel your medical device forward. From navigating regulatory standards like 21 CFR 820 and ISO 13485 to providing invaluable insights into product development projects, we ensure safe and effective products that meet regulatory scrutiny and surpass industry standards.

In addition to our core consulting services, we offer specialized support tailored to startup and small SaMD companies.

Our additional services include marketing consulting to enhance brand visibility and market penetration, fractional CTO services covering system architecture design, HIPAA compliance, data modeling, and tech consulting, as well as cybersecurity consulting to safeguard your digital assets and ensure compliance with industry regulations.

Whether you’re seeking to navigate regulatory complexities or enhance your technological capabilities, we have the expertise to propel your success.

Learn more

UNLOCKING STRATEGIC VALUE

The Role of Quality Management Systems and Auditing in Driving Organizational Excellence

A well-designed Quality Management System (QMS) isn’t just a regulatory requirement—it’s a strategic asset that can drive significant value for your organization. Investing in a robust QMS and partnering with a specialized Quality Group is an investment in the future of your business, not merely a cost center. A meticulously crafted QMS streamlines operations, enhances efficiency, and minimizes risks, ultimately leading to improved product quality and customer satisfaction.

To that end, auditing, often viewed as a compliance necessity, can be a remarkably valuable and enlightening activity. It not only ensures regulatory adherence but also provides insights that can uncover areas for improvement and risk reduction. By fostering a culture of continuous improvement through audits, organizations cultivate a robust quality culture where excellence is not just a goal but a way of doing business. Embracing the value of a well-designed QMS and recognizing the importance of auditing as a value-added activity are pivotal steps towards achieving sustained success in the competitive landscape of the Medical Device Industry.

Fission Consulting Services audits follow a risk-based approach and concentrate on areas where vulnerabilities may expose your organization to potential regulatory action. This proactive approach allows for necessary corrections to be implemented before they come to the attention of regulators. Offering up best practices based on dozens of Quality Systems reviewed also allows for reducing non-value added compliance work to allow you and your teams to focus on what really matters.

Elevate Your Medical Devices

In addition to our expertise in quality management systems, Fission Regulatory Services proudly offers cutting-edge medical device systems design engineering consulting services. Our seasoned team of engineers brings a wealth of experience and innovation to the table, specializing in designing products that meet the highest standards of efficacy, safety, and regulatory compliance. Whether you’re in need of assistance with medical device integration, software development, or clinical trials optimization, our consultants have the skills and insights to drive your projects to success. Partner with Fission Regulatory Services and experience firsthand the transformative power of strategic product development. Let us help you bring your innovative healthcare solutions to life, while ensuring compliance and efficiency every step of the way.

Let's chat

INTRODUCING FISSION’S EXPERT CONSULTANTS

Your Secret Weapon for Medical Device Success

Say hello to the powerhouse team at Fission Consulting Services! Our crew of consultants is here to help startups and small businesses in the medical device industry achieve success. Whether you need regulatory expertise, marketing mojo, tech wizardry, or cybersecurity savvy, our team of experts has the know-how to propel your business forward.

Jeremy Moore

Founder & Regulatory Consultant

Jeremy Moore is a seasoned quality professional with over 13 years of experience in Quality Assurance and Regulatory Compliance within the Medical Device Industry. With a track record of achieving regulatory milestones and driving impactful change, Jeremy brings invaluable expertise to every project. As a veteran of the US Navy, he is dedicated to excellence and continuous innovation in quality management.

LinkedIn

Caitlin Bates

Senior Marketing Consultant

Caitlin Bates is a healthcare marketing expert renowned for her passion for branding and crafting impactful campaigns. With over a decade of experience in digital marketing, Caitlin excels in navigating the complexities of the healthcare marketing landscape. As a consultant, her expertise promises to be a strategic partner in driving brand success and achieving marketing goals.

LinkedIn

Chris Middleton

Fractional CTO

Chris Middleton, Fission’s fractional CTO, is a lifelong technologist dedicated to healthcare innovation. With a focus on software solutions for neurological and cognitive diseases, Chris led tech initiatives at Avalon Metrics and Aural Analytics. His expertise includes strategic data analysis, patient recruitment, and software security. Chris’s passion for building impactful solutions drives his commitment to improving patient care.

LinkedIn

Laique Alhassan

Senior Cybersecurity consultant

Laique Alhassan is a dynamic Agile Delivery Manager skilled in Cloud Security, Cloud Migration, and Regulatory Compliance within Startup and Enterprise environments. With a focus on Agile methodologies and strategic risk management, Laique drives successful project delivery while fostering innovation and quality management systems. His expertise in Agile tools and technical skills ensures impactful outcomes for forward-thinking organizations.

LinkedIn

Case Study: Enhancing Compliance and Efficiency for a Dental and Surgical Instrument Manufacturer

When a leading dental and surgical instrument manufacturer sought to bolster their internal processes, they turned to Fission Consulting Services for assistance. Initially engaged for internal audits, our partnership expanded as critical gaps emerged in Corrective and Preventive Action (CAPA) processes and product validations.

Fission conducted a comprehensive assessment of the client’s extensive product line, comprising over 5000 SKUs. This evaluation led to the identification of worst-case devices for cleaning and sterilization validation, meticulously documented to meet FDA requirements. Collaborating closely with a reputable testing laboratory, we ensured the thorough validation of these devices, providing our client with confidence in their compliance measures.

In addition to product validation, Fission spearheaded a holistic overhaul of the client’s complaint management and CAPA system. By streamlining complaint intake and review procedures and optimizing repair request documentation, we eliminated redundant paperwork while maintaining a compliant Quality Management System.

The results were transformative. Our client experienced a significant improvement in compliance standards while simultaneously reducing administrative burdens. With Fission’s expert guidance, they were able to refocus their efforts on core business activities, secure in the knowledge that their compliance framework was robust and efficient.

“Fission Consulting Services was phenomenal in helping us navigate improving our state of compliance while reducing extraneous paperwork that was bogging us down and causing compliance issues. Their work was detailed and allowed us to focus on our business and not extra compliance work.”

Case Study: Establishing Regulatory Compliance for a Muscle Stimulator Device Company

When the CEO of a promising muscle stimulator device company acquired the assets of a defunct electromagnetic muscle stimulator designer, he recognized the potential to positively impact patients worldwide. However, as a medical device startup, he understood the critical importance of establishing a robust Quality Management System (QMS) within budget constraints. Fission Consulting Services was enlisted to develop a tailored QMS from scratch.

As our team embarked on building a bespoke QMS, an unexpected FDA visit resulted in a Form 483, highlighting compliance deficiencies. Fission swiftly assumed control of interactions with the regulatory agency, rectifying identified deficiencies and ensuring compliance with regulatory standards. Through our diligent efforts, the inspection concluded successfully without further regulatory action.

“Fission’s ability to take over interactions with the FDA allowed me to get back on the road to focus on growing my business and not managing compliance. Fission will continue to be an integral part of my company’s regulatory and quality operations for the foreseeable future.”

OUR SERVICES

Advance Your Quality, Development, and Regulatory Initiatives

At Fission Consulting Services, we offer a comprehensive suite of services tailored to meet the diverse needs of the medical device industry. Whether you require expert guidance in Quality Assurance, Design and Development, Regulatory Affairs, or Clinical Affairs, our team is equipped to deliver results that exceed expectations.



Quality Assurance

Internal Quality System Audits
- 21 CFR 820
- ISO 13485
- MDSAP
- EU MDR
- ISO 9001
Supplier Quality Audits
Supplier and Vendor Quality Oversight
21 CFR Part 11 Assessment and Remediation
Quality Management System Development
Gap Assessments and QMS improvement
Fractional Head of Quality
Quality Team Augmentation



Design and Development

Design Project Planning
DHF Development and Remediation
Risk Management
Design Transfer
Development Team Augmentation



Regulatory

New product Regulatory Assessments
Expanding Indications for Use
Regulatory roadmap development and planning
Submissions

FDA Pre-submissions/Q-Sub Meetings
FDA Breakthrough Applications
FDA Small Business Designation
US FDA 510(k) Clearance
CE Mark
De Novo
PMA



Clinical Affairs

Clinical Evaluation Reports
GCP Auditing and Study Site Oversight
Clinical Process and Protocol Development



Marketing

Brand development
Strategic planning
Content strategy and deployment
Social media management
Ad campaigns
Web development and optimization
Email marketing
Analytics and reporting

Contact Us Today to Learn More