What Regulatory Technology Services does

Regulatory Technology Services (RTS) is a privately held LLC headquartered in Saint Paul, Minnesota that operates as an FDA-accredited Third-Party Review Organization (3PRO) under Section 523 of the Federal Food, Drug, and Cosmetic Act. The company reviews 510(k) premarket notification submissions for low-to-moderate risk Class I and Class II medical devices on behalf of manufacturers, forwarding a Substantially Equivalent (SE) or Not Substantially Equivalent (NSE) recommendation to the FDA, which is committed to issuing a final determination within 30 days. RTS has held 3PRO accreditation since 2003, was re-authorized in 2020, and is the only third-party reviewer accredited across all twenty FDA medical specialties/review panels.

RTS generates revenue through a transaction-fee model: medical device manufacturers pay RTS directly for each 510(k) review, with no separate payment owed to the FDA. The company's go-to-market is direct and sales-led, primarily through its website (rts3pro.com), online application form, and direct phone and email contact. RTS has accumulated 1,500+ 510(k) reviews since 2003 and reports the highest annual review volume of any 3PRO in the industry, with named customers spanning large multinationals (Siemens Healthineers, FUJIFILM Sonosite, ICU Medical) and smaller specialty manufacturers across imaging, dental, surgical, and disposable device categories. Headcount is in the 11-50 range.

The core operational capability is human regulatory review expertise rather than software or AI; RTS applies the same review criteria used by the FDA and typically completes reviews in 14 days versus the 90 days permitted for a Traditional 510(k) reviewed directly by the agency. The company is subject to FDA audit every three years, with no disclosed funding rounds, M&A activity, partnerships, or executive changes in the available data.

Name

Regulatory Technology Services

Legal name

Regulatory Technology Services LLC

Website

https://rts3pro.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

RTS is an FDA-accredited Third-Party Review Organization that conducts 510(k) premarket reviews for low-to-moderate risk Class I and Class II medical devices. It serves medical device manufacturers across all twenty FDA medical specialties, completing reviews in approximately 14 days versus the FDA's 90-day standard timeline.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Review Services

NAICS

Testing Laboratories and Services (541380), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

akta.pro secondary industry

Medical Device Regulators (HLAJADAC)

Keywords

• FDA 510(k) review
• Third-party review organization
• Medical device regulatory clearance
• 510(k) submission review
• Regulatory compliance services

Headquarters

HQ city

Saint Paul

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Revenue model

1. 510(k) Review Services: Medical device manufacturers pay the 3PRO (RTS) for conducting the 510(k) review. There is no separate payment owed to the FDA. This is a transaction-based fee model per submission reviewed.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Regulatory Technology Services is an FDA-accredited Third-Party Review Organization (3PRO) that conducts 510(k) premarket notification reviews for low-to-moderate risk Class I and Class II medical devices. Manufacturers submit their 510(k) directly to RTS, which applies the same review criteria used by FDA, completes substantive reviews in roughly 14 days (administrative review within 24 hours), and forwards its Substantially Equivalent or Not Substantially Equivalent recommendation to FDA for final determination. RTS is the only 3PRO accredited to review devices across all twenty FDA medical specialties and review panels, with 1,500+ reviews completed since 2003.

Product overview

Regulatory Technology Services (RTS) operates as a single-service company offering FDA-accredited Third-Party 510(k) Review services. The company provides one core offering: the FDA 3P510K Review Service, which allows medical device manufacturers to submit their 510(k) premarket notifications to RTS instead of directly to the FDA for review. RTS utilizes the same review criteria as the FDA and typically completes reviews in 14 days, forwarding their recommendation to the FDA for final decision. RTS is the only third-party review organization accredited to review medical devices across all twenty FDA medical specialties/review panels.

Differentiator

Problem solved

Functional benefit

Products and services

• FDA 3P510K Review Service FDA-accredited Third-Party Review Organization (3PRO) service that reviews 510(k) submissions for low-to-moderate risk Class I and Class II medical devices. Manufacturers submit their 510(k) directly to RTS, which applies the same review criteria as the FDA, completes substantive reviews in about 14 days, and forwards its Substantially Equivalent (SE) or Not Substantially Equivalent (NSE) recommendation to FDA for a final determination committed within 30 days.

Quantifiable outcome

• 14-day average turnaround time vs. 90-day standard FDA review
• +2 more outcomes

Named customers18 records

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators4 records

Recent moves4 records

Expansion highlights3 records

Broad incumbents

• DNV: DNV is a global assurance and certification firm offering medical device regulatory services including FDA 3PRO review. It overlaps with RTS in 510(k) third-party review while serving healthcare manufacturers across quality management certification and risk management standards.
• NAMSA: NAMSA is a medical device-focused Contract Research Organization offering regulatory, testing, and quality consulting services. It competes with RTS for medical device manufacturer clients seeking regulatory pathway support, though its breadth extends well beyond 510(k) review into preclinical and clinical research.
• Intertek: Intertek is a global testing, inspection, and certification firm with FDA 3PRO accreditation for medical devices. It competes with RTS on third-party review while offering substantially broader services including product safety testing, EMC, and life sciences assurance.
• TÜV Rheinland: TÜV Rheinland is a global testing and certification organization with medical device notified body status. It overlaps with RTS on regulatory review and serves the same manufacturer customer base, but at materially larger scale and broader geographic scope.
• UL LLC (Underwriters Laboratories): UL Solutions is a large global testing and certification company with FDA 3PRO accreditation. It competes with RTS on 510(k) third-party review while serving medical device manufacturers through its broader safety science, testing, and advisory portfolio.
• Eurofins Scientific: Eurofins is a global testing services group with a dedicated medical device division. It provides adjacent regulatory and laboratory testing services to medical device manufacturers comparable to RTS's customer base, though its primary scale is in bioanalytical and product testing.
• SGS: SGS is one of the world's largest testing, inspection, and certification companies, holding FDA 3PRO status and notified body designations. It overlaps with RTS on medical device regulatory review but competes primarily as a broad incumbent across multiple industries.

Direct peers

• RQM+: RQM+ (formerly R&Q) is a medical device regulatory and quality consulting firm with FDA 3PRO credentials. It directly competes with RTS for 510(k) review and related regulatory services, particularly for early-stage and mid-sized device manufacturers.
• BSI Group: BSI is a major FDA-accredited 3PRO and global notified body for medical devices. It directly competes with RTS in US 510(k) third-party review and bundles the service with ISO 13485 and international regulatory work for the same manufacturer customer base.
• TÜV SÜD America: TÜV SÜD America is an FDA-accredited Third-Party Review Organization and one of the largest global notified bodies for medical devices. It directly competes with RTS for US 510(k) third-party review work while offering a far broader portfolio of testing, certification, and EU MDR services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/regulatory-technology-services

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Regulatory Technology Services