Sequence Group
- Company typePrivate
- Founded2023
- HeadquartersFort Lauderdale, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
Sequence Group firmographics
Firmographics- Name
- Sequence Group
- Legal name
- Sequence Group, LLC
- Website
- https://sequencemedtech.com
- Company type
- Private
- Founded year
- 2023
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Ownership category
- akta.pro rank
Sequence Group industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industries
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)
Keywords
Where Sequence Group is headquartered
LocationHeadquarters
- HQ city
- Fort Lauderdale
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Sequence Group business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales
Revenue model
- Regulatory Consulting Services: The company generates revenue through consulting engagements providing regulatory strategy, 510(k) and De Novo submission preparation, EU MDR compliance support, QMS development, and design control services for medical device companies.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Consulting services with custom project-based pricing |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels1 record
Sequence Group product offering
Product offeringCore offering
Sequence Group provides regulatory and quality consulting services to medical device manufacturers. The firm guides clients through device design, development, FDA 510(k) and De Novo submissions, EU MDR 2017/745 compliance, quality management system (QMS) development aligned with ISO 13485, design controls, post-market support, and US Agent services for foreign manufacturers. Additional offerings include a QMS platform (Sequence QMS) and an online store (Sequence MedTech Store) selling curated regulatory books, standards, and compliance tools.
Product overview
Sequence Group is a medical device consulting firm providing expert guidance and support in device regulatory consulting and medical device design and development. The company offers a comprehensive suite of consulting services including regulatory submissions (510(k), EU MDR), market research, project planning, development lifecycle management, post-market support, and US Agent Services for foreign manufacturers. Their portfolio of completed consulting projects includes regulatory support for specific medical devices such as the Sculptura IORT System, GentleBeam™ radiation therapy system, TVM Balloon Applicator, Treatment Planning System (TPS), and SRT-100 Plus. The company also maintains a QMS platform at sequenceqms.com and an online store for medical device regulatory resources at store.sequencemedtech.com.
Differentiator
Problem solved
Functional benefit
Brands
- Sequence QMS: Quality Management System platform and services
- Sequence MedTech Store
Products and services
- Device Regulatory Consulting Expert guidance and support navigating regulatory challenges for medical device companies, including FDA submissions (510(k), De Novo) and EU MDR 2017/745 compliance. Targets medical device manufacturers bringing products to market in the US and EU.
- Medical Device Design and Development Comprehensive consulting support for medical device design and development from inception through regulatory submission and market launch, covering design controls and design history file preparation.
- Market Research Evaluation of medical devices and market research services to help determine appropriate regulatory and market pathways for device commercialization.
- Project Planning Development planning services providing a structured approach to ensure project success for medical device development programs.
- Development Lifecycle Services Guidance through each step of the device development process, including final device preparation and regulatory submission.
- Post Market Support Post-market support services to help medical device organizations remain compliant with regulatory obligations after device launch, including post-market surveillance.
- US Agent Services FDA-designated US Agent services for foreign manufacturers, handling FDA correspondence, registration, and compliance obligations on their behalf.
- Sequence MedTech Store E-commerce storefront at store.sequencemedtech.com selling curated regulatory books, standards, and compliance tools for FDA, ISO, and EU MDR professionals across approximately 24 products and 8 categories.
- Sequence QMS Quality Management System platform and related services hosted at sequenceqms.com, supporting ISO 13485-aligned QMS implementation, software validation, and generation change management.
Companies that use Sequence Group
Customer profileNamed customers2 records
Segments1 record
Ideal customer profiles2 records
Sequence Group technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Sequence Group partnerships and signals
Strategic signalScale indicators6 records
Recent moves5 records
Expansion highlights5 records
Sequence Group competitors and assessment
Company assessmentEmerging players
- Greenlight Guru: Greenlight Guru offers a QMS platform plus regulatory and quality consulting tailored to medical device companies pursuing ISO 13485/FDA compliance. Comparable as a med-device-focused regulatory/QMS service provider, but adds a SaaS platform layer Sequence Group does not yet match.
- Rimsys: Rimsys provides regulatory information management (RIM) software for medical device and diagnostics companies to manage global submissions, registrations, and compliance. Comparable as a med-device regulatory workflow vendor; while software-led rather than consulting-led, it competes for the same budget Sequence Group targets.
- AssurX: AssurX delivers QMS, regulatory, and compliance management software for life sciences manufacturers. Overlaps with Sequence Group's consulting on quality system implementation, though it primarily competes via software rather than services.
Broad incumbents
- MasterControl: MasterControl provides enterprise QMS and quality consulting software primarily for life sciences manufacturers including medical device companies. Comparable in addressing the same QMS and regulatory compliance needs, but as a major software incumbent rather than a boutique consultancy.
- NAMSA: NAMSA is a large medical device-focused CRO offering regulatory, testing, and clinical services across the full product lifecycle. Comparable in regulatory submission expertise, but with far greater scale and a testing-oriented portfolio that Sequence Group does not offer.
Others
- MedDevice CORP / Creganna (part of Molex): Creganna (now part of Molex) provides design, development, and regulatory support services for medical device manufacturers, including regulatory strategy and submission support. Comparable in regulatory service capability, though embedded within a much broader contract manufacturing/services conglomerate.
Direct peers
- MethodSense: MethodSense provides regulatory, quality, and clinical consulting specifically for medical device and IVD manufacturers, including FDA submissions, ISO 13485, and EU MDR. Directly comparable niche competitor with similar service mix and customer base.
- Quality-One International: Quality-One offers life sciences consulting including quality, regulatory, validation, and engineering services for medical device and pharma manufacturers. Directly comparable in scope with emphasis on QMS, validation, and remediation work.
- Regulatory Compliance Associates (RCA): RCA specializes in life sciences regulatory compliance consulting across pharma, medical devices, and combination products, including FDA submissions, QMS, validation, and remediation. Comparable to Sequence Group in regulatory services orientation though broader in life-sciences scope.
- MEDIcept: MEDIcept is a medical device regulatory and quality consulting firm offering 510(k), De Novo, CE Marking/EU MDR, QMS implementation, design controls, and post-market services. Closely comparable boutique to Sequence Group in scope, customer profile, and delivery model.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Sequence Group social profiles
Digital presenceSequence Group compliance and trust
Trust signalCompliance11 records
Sequence Group financial estimates
Financial estimateRevenue estimate
Valuation estimate
Sequence Group leadership team
Management profileNumber of profiles
Sequence Group funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Sequence Group M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Sequence Group
What does Sequence Group do?
Sequence Group provides regulatory and quality consulting services to medical device manufacturers. The firm guides clients through device design, development, FDA 510(k) and De Novo submissions, EU MDR 2017/745 compliance, quality management system (QMS) development aligned with ISO 13485, design controls, post-market support, and US Agent services for foreign manufacturers. Additional offerings include a QMS platform (Sequence QMS) and an online store (Sequence MedTech Store) selling curated regulatory books, standards, and compliance tools.
Is Sequence Group a public or private company?
Sequence Group is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Sequence Group founded?
Sequence Group was founded in 2023. It employs 1 to 10 people.
Where is Sequence Group based?
Sequence Group is headquartered in Fort Lauderdale, United States, in the North America region.
How does Sequence Group make money?
One revenue line is on record: regulatory Consulting Services.
Who are Sequence Group's main competitors?
Emerging players on record are Greenlight Guru, Rimsys and AssurX. Broad incumbents are MasterControl and NAMSA. MedDevice CORP / Creganna (part of Molex) is listed as an others. Direct peers are MethodSense, Quality-One International, Regulatory Compliance Associates (RCA) and MEDIcept.
Does Sequence Group have an API?
No public API is recorded for Sequence Group.
What industry is Sequence Group in?
Sequence Group's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation. Its SIC code is 3841.