Regulatory, quality and product development
The decisions you make early (in design, in protecting your idea and in choosing an FDA pathway) shape how fast you reach market and how readily clinicians, patients and buyers accept and adopt your product. Whether you’re developing a medical device, a drug or biologic, a diagnostic, or medical software, Shorelight Medical and our partners help you design it right, protect it, choose the right FDA route, and build a quality system that passes inspections and protects patients.
Who It's For
- Life science and medtech companies of any kind (devices, pharmaceuticals, diagnostics, digital health and software) unsure which FDA pathway applies
- International companies registering with FDA to sell in the US
- Growing companies preparing for FDA inspections, audits or certification
- Inventors, clinicians and startups turning an idea into a product
What's included
Product development and engineering
- IP protection: patent strategy and freedom-to-operate review, coordinated with our patent counsel partners
- Engineering and design: turning your concept into detailed designs and specifications
- Prototyping and MVP development: functional prototypes and a minimum viable product (MVP) for testing, user feedback, pilots and investor demos
- Design controls: the documentation FDA expects, built in from day one
- Design for manufacturing: designs that move smoothly into production at a sensible cost
Regulatory strategy and submissions
- FDA strategy and pathway assessment: classification and the right route for your product, for example 510(k), De Novo or PMA for devices and diagnostics, or IND and NDA/ANDA for drugs
- Submission preparation: building and submitting your FDA application with our regulatory partners
- FDA registration and listing: establishment registration and product listing
- US Agent coordination: through our partners, for foreign companies that must name a US Agent
- Clinical and lab testing: coordinating studies, test labs and approvals
Quality and compliance
- Quality management system (QMS): setup to the standards your product requires, such as ISO 13485 and FDA's device quality rules, or cGMP for drugs
- Audit and inspection readiness: mock audits and supplier audits before FDA or a certification body visits
- Compliance and regulatory advisory: ongoing guidance as your product, suppliers and markets change
- Post-market compliance: complaint handling, adverse-event reporting and recall-risk reduction
How it works
1. Free 1-hour discovery call
Under NDA if you prefer, we review your product, its stage of development and where you stand with FDA. No cost and no obligation.
2. Proposal
If there’s a fit, we send a written proposal with scope, timeline and fees. Paid work, including a full gap assessment or further discovery sessions, begins only after you approve it.
Strategy
We set your IP approach and recommend an FDA pathway with timeline and cost.
4. Develop and Submit
We design and prototype, build your quality system, and prepare your submission.
5. Stay Compliant
We support inspections, changes and post-market reporting.
Why Shorelight
Through our regulatory, engineering and patent counsel partners, we support devices, drugs, diagnostics and software from first design to post-market, with one Shorelight team managing the process.
- More than 30 years of combined experience in medtech and life science commercialization, spanning sales, product development, marketing strategy and market launch.
- Founder-led. Founder and CEO Stephen Brown brings 17 years of sales experience, 13 of them in medical device sales, along with experience in product development and new product launches.
- Marketing and commercialization expertise. Our team brings marketing strategy and execution plus hands-on commercialization experience, so your product launches with a clear message and a plan to reach buyers.
- One team, trusted partners. A vetted network of partners across every service (product development, regulatory and quality, reimbursement and market access, sales and marketing, and manufacturing and supply chain), all coordinated by Shorelight.
FAQ
Is my idea protected when I share it with you?
We sign an NDA before any detailed discussion.
What types of products do you support?
Medical devices, pharmaceuticals and biologics, diagnostics, digital health and software as a medical device, and combination products, through our regulatory partners.
How long does FDA review take?
- It depends on the pathway. FDA’s current performance goals for medical devices (MDUFA V, fiscal years 2025–2027) are:
- 510(k): 90 FDA review days (about 112 calendar days in total)
- De Novo: 150 FDA review days
- PMA: 180 FDA review days, or 320 days if an advisory panel is needed (about 285 calendar days in total on average)
“FDA review days” exclude time spent waiting on the applicant to answer FDA’s questions, so calendar time is longer. Development, testing and submission preparation come before the review clock starts. For new drugs and biologics, FDA’s goal is typically 10 months for a standard review and 6 months for a priority review.
Do foreign companies need a US Agent?
Yes. FDA requires foreign establishments that register with it to identify a US Agent. Shorelight isn’t a US Agent, but we coordinate this through our partners as part of your registration.
Have a product idea, or not sure which FDA pathway fits?
Let’s talk.
Schedule a discovery call: a one-hour conversation where we get to know your product, your company and your goals, so we can see if and how we can help.