SQI
SQI is a French employee-owned cooperative that provides custom IEC 62304-compliant software development and regulatory affairs consulting for medical device manufacturers, startups, and research institutions, covering surgical planning, robotics, navigation, and CE/FDA certification.
- Company typePrivate
- Founded2008
- HeadquartersMeylan, France
- Headcount11–50
- GTM typeB2B
- OfferingServices
What SQI does
SQI (SurgiQual Institute) is a French employee-owned cooperative (SCOP) founded in 2008 and headquartered in Meylan, near Grenoble. The firm delivers two tightly integrated service lines to medical device manufacturers, research laboratories, and academic medical centers: custom IEC 62304-compliant software development and quality/regulatory affairs consulting. The software portfolio comprises four modules: surgical planning software (digital patient twins, implant simulation, 3D modeling), intraoperative navigation systems with augmented reality, medical robotics integration (precision positioning, autonomous trajectory execution, real-time feedback loops), and workflow management platforms interfacing with medical devices for health data and fleet supervision. The QARA consulting services cover regulatory strategy, clinical investigation support, CE/FDA market authorization, and ISO 13485/21 CFR Part 820 quality management system implementation. SQI's combined software-plus-regulatory model allows clients to move from proof of concept through certified product within a single vendor relationship, an unusual capability that the firm leverages to support enterprise OEMs (Medtronic, Staubli, Renishaw, Ecolab, Edap TMS, Olympus, Corin), startups (Modjaw, MagIA, Moon Surgical), and public-sector institutions (CEA, IHU Strasbourg, CHU Grenoble Alpes).
The firm operates exclusively through direct B2B engagement with project-based, multi-year contracts and no public pricing. SQI holds its own ISO 13485:2016 certification, enabling it to assume manufacturer regulatory responsibility for non-CE-marked devices during clinical investigations, a permission that few competing consultancies hold. The company employs 38 people, reports 150+ clients and 16,000+ patient outcomes, and maintains Bpifrance institutional recognition as referenced experts. Revenue is undisclosed; based on headcount and the disclosed EUR 50-65K QARA consultant salary band, implied annual revenue is in the single-digit to low-double-digit million EUR range. Go-to-market relies on direct sales, a bilingual corporate website, and LinkedIn presence, with no advertising, content marketing, or channel partners identified.
SQI firmographics
Firmographics- Name
- SQI
- Legal name
- SurgiQual Institute (SQI)
- Website
- https://sqi.coop
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- SQI is a French employee-owned cooperative that provides custom IEC 62304-compliant software development and regulatory affairs consulting for medical device manufacturers, startups, and research institutions, covering surgical planning, robotics, navigation, and CE/FDA certification.
- Ownership category
- akta.pro rank
SQI industry classification
Industry- Product category
- Medical Device Software Development and Regulatory Consulting
- NAICS
- Custom Computer Programming Services (541511), Computer Systems Design and Related Services (54151)
- SIC
- Services-Computer Programming Services (7371), Services-Computer Programming, Data Processing, Etc. (7370)
- akta.pro primary industry
- Quality Engineering & Test Automation (QE/QA) (BPAEAFAJ)
Keywords
Where SQI is headquartered
LocationHeadquarters
- HQ city
- Meylan
- HQ country
- France
- HQ region
- Europe
Offices2 records
Markets served
SQI business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales
Revenue model
- Custom Software Development Services: Bespoke design and development of medical device software from proof of concept to certified product. Services include surgical planning applications, navigation systems, robotics integration, and workflow management platforms. Pricing is project-based, reflecting the custom nature of development work.
- Quality and Regulatory Consulting: Regulatory strategy, clinical investigation support, CE/FDA market authorization, and quality management system implementation. Services span from research to market across all medical device types including in vitro diagnostics. Certification support includes ISO 13485 and 21CFR Part 820 compliance.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
SQI product offering
Product offeringCore offering
SQI designs and develops custom software for medical devices, from proof of concept through certified product, covering surgical planning, intraoperative navigation, medical robotics integration, and business workflow management. The firm also provides integrated quality and regulatory affairs consulting, including regulatory strategy, clinical investigations, CE/FDA market authorization, and quality management system implementation. Services are delivered on a project basis with IEC 62304 compliance embedded throughout the software development lifecycle.
Product overview
SQI (SurgiQual Institute) operates as a SCOP (cooperative company) offering two integrated service areas: Software Development and Quality & Regulatory Affairs (QARA) consulting. The software portfolio includes four modules—Surgical Planning Software for pre-operative planning, Clinical Gesture Guidance Navigation Systems for intra-operative navigation, Medical Robotics Integration for robot control, and Business Workflow Management Software for data management. The QARA consulting services encompass Regulatory Strategy, Clinical Investigations Support, CE/FDA Market Authorization, Quality Management System Implementation, and Specific Expertise Services. These offerings are designed to work together, enabling clients to develop medical devices from proof of concept through certified product with integrated regulatory compliance.
Differentiator
Problem solved
Functional benefit
Products and services
- Surgical Planning Software
Quantifiable outcome
- 10+ CE markings and ISO 13485 certifications obtained for clients
- +3 more outcomes
Companies that use SQI
Customer profileNamed customers20 records
Segments4 records
Ideal customer profiles4 records
SQI technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability7 records
Feature5 records
SQI partnerships and signals
Strategic signalScale indicators6 records
Recent moves6 records
Expansion highlights6 records
SQI competitors and assessment
Company assessmentBroad incumbents
- Capgemini Engineering: Capgemini Engineering (formerly Altran) is a large global engineering services firm with a Life Sciences division providing software development, systems engineering, and regulatory support to medical device manufacturers. It competes broadly with SQI in medical device software and digital health engagements.
- ICON plc: ICON plc is a large global contract research organization with a Medical Device and Diagnostics practice offering regulatory, clinical investigation, and quality services. It is comparable to SQI's clinical investigation and CE/FDA market authorization consulting at materially greater scale.
- TÜV SÜD: TÜV SÜD is a global testing, inspection, and certification body that provides medical device testing, certification, and quality management services under ISO 13485, MDR, and FDA frameworks. It is comparable to SQI on the QARA and certification-support side of the business.
- Parexel International: Parexel is a large global CRO with a Medical Device and Diagnostics consulting practice providing regulatory affairs, clinical, and quality services to device manufacturers. It is comparable to SQI's clinical investigation support and CE/FDA consulting business lines.
- Akkodis: Akkodis is a global engineering services and consulting firm with a dedicated Life Sciences and Medical Devices practice delivering software, regulatory, and digital engineering support to MedTech clients. It competes with SQI across the integrated software + regulatory value proposition at materially greater scale.
- BSI Group: BSI Group is a global standards and certification organization with a dedicated Medical Devices practice offering ISO 13485 certification, CE marking, and regulatory consulting. It is comparable to SQI's regulatory certification support practice but operates at much larger scale.
- DEKRA: DEKRA is a global testing, inspection, and certification organization with medical device product testing, certification, and quality system services. It overlaps with SQI's regulatory and quality management consulting practice for medical device manufacturers.
Direct peers
- Maetrics: Maetrics is a specialist medical device regulatory affairs and quality compliance consulting firm serving device manufacturers in Europe and North America. Its narrow focus on MedTech QARA closely mirrors SQI's regulatory consulting practice and target customer base.
- NAMSA: NAMSA is a US-headquartered medical device-focused contract research organization offering regulatory, quality, clinical, and testing services for medical device manufacturers. It is the most directly comparable peer to SQI's combined software + regulatory offering for MedTech clients.
Emerging players
- Greenlight Guru: Greenlight Guru is a software company offering a cloud-based quality management system (eQMS) and medical device compliance platform. While it is product rather than services-based, it competes with SQI's QMS implementation and ISO 13485 consulting practice by offering an alternative self-service route for medical device manufacturers.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
SQI social profiles
Digital presenceSQI compliance and trust
Trust signalCompliance3 records
SQI financial estimates
Financial estimateRevenue estimate
Valuation estimate
SQI leadership team
Management profileNumber of profiles
Profiles2 records
SQI funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SQI 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 SQI
What does SQI do?
SQI designs and develops custom software for medical devices, from proof of concept through certified product, covering surgical planning, intraoperative navigation, medical robotics integration, and business workflow management. The firm also provides integrated quality and regulatory affairs consulting, including regulatory strategy, clinical investigations, CE/FDA market authorization, and quality management system implementation. Services are delivered on a project basis with IEC 62304 compliance embedded throughout the software development lifecycle.
Is SQI a public or private company?
SQI is a private company. It is classified as management employee owned and is currently operating.
When was SQI founded?
SQI was founded in 2008. It employs 11 to 50 people.
Where is SQI based?
SQI is headquartered in Meylan, France, in the Europe region.
How does SQI make money?
Two revenue lines are on record. Custom Software Development Services are the primary driver. The others are quality and Regulatory Consulting.
Who are SQI's main competitors?
Broad incumbents on record are Capgemini Engineering, ICON plc, TÜV SÜD, Parexel International, Akkodis, BSI Group and DEKRA. Direct peers are Maetrics and NAMSA. Greenlight Guru is listed as an emerging player.
Does SQI have an API?
No public API is recorded for SQI.
What industry is SQI in?
SQI's product category is Medical Device Software Development and Regulatory Consulting. Its primary akta.pro industry code is BPAEAFAJ, Quality Engineering & Test Automation (QE/QA). Its NAICS code is 541511 and its SIC code is 7371.