Sertio Oy
Sertio Oy is a Finland-based, EU-designated Notified Body (IVDR 2017/746) and FINAS-accredited ISO 13485 certification body providing conformity assessment, technical documentation review, and QMS audit services to IVD manufacturers, operators, and sterilization providers globally.
- Company typePrivate
- Founded2021
- HeadquartersTampere, Finland
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Sertio Oy does
Sertio Oy is a Finland-based, EU-designated Notified Body under In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and a FINAS-accredited ISO 13485 certification body, headquartered at Biokatu 10, Tampere. The company delivers conformity assessment services for IVD medical devices across all risk classes requiring notified body involvement — Class A sterile, Class B, Class C, and Class D — including companion diagnostics, self-testing, and near-patient testing devices under Annex IX. Its core technical offering comprises technical documentation review, performance evaluation assessment, multi-stage QMS audits (Stage 1 and Stage 2), and issuance of EU certificates with up to five-year validity, supplemented by annual surveillance and unannounced audits.
The firm also provides FINAS-accredited ISO 13485 quality management system certification to IVD manufacturers, IVD operators, and sterilization service providers, including a certificate transfer pathway that allows migration from other certification bodies. A separate Article 16 QMS assessment service addresses importers and distributors that relabel or repackage IVD devices. Revenue is generated through professional-services fees: quotation-based application and audit fees for new engagements, plus recurring surveillance and recertification fees across the multi-year certificate lifecycle. GTM is sales-led and enterprise-focused, with lead capture via online quote-request and contact forms on sertio.fi and a multi-stage funnel of quotation, application, contract, audits, and certification decision.
Effective 1 May 2026, Sertio Oy was acquired by Kiwa Oy, one of the world's leading testing, inspection, and certification companies operating in more than 35 countries. Sertio continues to operate under its own brand as 'Sertio - a Kiwa company,' retaining exclusive IVD specialization while gaining access to Kiwa's international network and roughly 700 Finnish experts across 24 locations. The standalone company is small (1–10 employees) and was founded in 2021.
Sertio Oy firmographics
Firmographics- Name
- Sertio Oy
- Legal name
- Sertio Oy
- Website
- https://sertio.fi
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Sertio Oy is a Finland-based, EU-designated Notified Body (IVDR 2017/746) and FINAS-accredited ISO 13485 certification body providing conformity assessment, technical documentation review, and QMS audit services to IVD manufacturers, operators, and sterilization providers globally.
- Ownership category
- akta.pro rank
Sertio Oy industry classification
Industry- Product category
- Medical Device Certification Services
- NAICS
- Testing Laboratories and Services (541380)
- SIC
- Services-Testing Laboratories (8734)
- akta.pro primary industry
- In Vitro Diagnostics (IVD) Regulators (HLAJADAD)
- akta.pro secondary industry
- Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)
Keywords
Where Sertio Oy is headquartered
LocationHeadquarters
- HQ city
- Tampere
- HQ country
- Finland
- HQ region
- Europe
Offices1 record
Markets served
Sertio Oy business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D
Revenue model
- IVDR Notified Body Certification Services: Conformity assessment services for EU IVDR compliance including technical documentation review, QMS audits, and certificate issuance for Class A sterile, Class B, Class C, and Class D IVD devices. Revenue generated through application fees, quotation-based service fees, and annual surveillance audit fees.
- ISO 13485 Certification Services: FINAS accredited quality management system certification for IVD manufacturers, operators, and sterilization service providers. Includes initial certification and certificate transfer services with associated audit and certification fees.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | IVDR Notified Body Services - Quote-based pricing |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels3 records
Sertio Oy product offering
Product offeringCore offering
Sertio Oy is an EU Notified Body under IVDR (Regulation EU 2017/746) providing conformity assessment services for In Vitro Diagnostic Medical Devices across Class A sterile, B, C, and D risk classes, including companion diagnostics. The company also operates as a FINAS accredited ISO 13485 certification body, issuing quality management system certifications for IVD manufacturers, IVD operators, and sterilization service providers. Services include technical documentation review, QMS audits (Stage 1 and Stage 2), certificate issuance with up to 5-year validity, annual surveillance audits, and Article 16 QMS assessments for importers and distributors.
Product overview
Sertio Oy is a notified body providing conformity assessment services for In Vitro Diagnostic Medical Devices (IVD) under EU Regulation 2017/746 (IVDR) and FINAS-accredited ISO 13485 quality management system certification. The core offerings consist of IVDR NB Certification Services covering all IVD device risk classes (A sterile, B, C, D) and companion diagnostics, and ISO 13485 Certification services including initial certification and certification transfer for IVD manufacturers, operators, and sterilization service providers. Sertio Oy also offers Article 16 QMS assessment for importers and distributors who relabel/repackage IVD devices. The company was acquired by Kiwa Oy in May 2026, expanding access to Kiwa's international network.
Differentiator
Problem solved
Functional benefit
Products and services
- IVDR Notified Body Certification Services Conformity assessment services as a notified body under EU Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices, covering Class A sterile devices (Annex IX), Class B, Class C, Class D devices, companion diagnostics, self-testing and near-patient testing devices, and Article 16 QMS assessments for importers and distributors. Targeted at IVD manufacturers seeking CE marking and EU market access.
- ISO 13485 Certification Services FINAS accredited quality management system certification for IVD manufacturers, IVD operators, and sterilization service providers globally. Includes initial certification (quotation, application review, Stage 1 audit, Stage 2 audit, resolution of nonconformities, certificate issuance) and certification transfer services from another certification body without re-audit.
Companies that use Sertio Oy
Customer profileSegments4 records
Ideal customer profiles3 records
Sertio Oy technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Sertio Oy partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Kiwa OycoreSertio Oy has joined Kiwa Oy effective 1.5.2026. The acquisition strengthens Sertio's position as a trusted expert in conformity assessment for in vitro diagnostics and gives customers access to Kiwa's extensive international network and expertise. Kiwa is one of the world's leading testing, inspection, and certification companies, operating globally in more than 35 countries with nearly 700 experts across 24 locations in Finland. Sertio maintains its high level of expertise, service quality, and customer focus while benefiting from Kiwa's global reach.
Scale indicators4 records
Recent moves5 records
Expansion highlights5 records
Sertio Oy competitors and assessment
Company assessmentDirect peers
- SGS: SGS is one of the world's largest TIC companies with IVDR Notified Body designation, providing medical device certification, testing, and inspection. It competes with Sertio for IVDR conformity assessment mandates from IVD manufacturers seeking EU CE marking.
- TÜV Rheinland: TÜV Rheinland is a global TIC company with IVDR Notified Body designation, offering conformity assessment and ISO 13485 certification for IVD manufacturers. It competes directly with Sertio across the same customer base of IVD manufacturers seeking EU market access.
- TÜV SÜD: TÜV SÜD operates a designated IVDR Notified Body providing conformity assessment for in vitro diagnostic medical devices globally. As one of the most established TIC providers, TÜV SÜD competes directly with Sertio in IVDR certification, QMS audits, and ISO 13485 services.
- Intertek: Intertek operates a notified body for IVDR providing certification and quality assurance services for IVD medical device manufacturers globally. It is a direct competitor with overlapping scope in conformity assessment and ISO 13485 certification for IVDs.
- DEKRA: DEKRA is a major international TIC organization with notified body services under IVDR, providing certification, testing, and auditing for medical devices including IVDs. It overlaps with Sertio on IVDR conformity assessment and ISO 13485 certification.
- BSI Group: BSI is one of the world's largest notified bodies designated under IVDR (EU 2017/746), providing conformity assessment for IVD manufacturers across all risk classes. BSI is the most direct competitor to Sertio given overlapping IVDR scope and similar enterprise sales motion targeting manufacturers seeking EU CE marking.
Broad incumbents
- Bureau Veritas: Bureau Veritas is a global TIC major with medical device certification capabilities including IVDR services. While broader in scope than Sertio, it competes in the IVD notified body space and offers overlapping conformity assessment services.
- Kiwa Oy: Kiwa is Sertio's parent company (acquired May 2026) and a leading global TIC firm operating in 35+ countries. While Sertio operates as a focused IVD specialist under Kiwa, Kiwa itself provides broader testing, inspection, and certification across multiple industries, making it both parent and adjacent competitor.
- UL Solutions: UL Solutions provides medical device testing, certification, and regulatory services including for IVDs, with notified body activities. It is comparable to Sertio through overlapping IVD certification and quality assurance offerings, though broader in industry coverage.
Emerging players
- Eurofins Scientific: Eurofins provides testing, certification, and regulatory compliance services for the medical device and IVD industry, including notified body-adjacent activities. It is comparable to Sertio through its IVD testing and regulatory service portfolio, though not a designated NB.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
Sertio Oy social profiles
Digital presenceSertio Oy compliance and trust
Trust signalCompliance2 records
Sertio Oy financial estimates
Financial estimateRevenue estimate
Valuation estimate
Sertio Oy leadership team
Management profileNumber of profiles
Sertio Oy funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Sertio Oy 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 Sertio Oy
What does Sertio Oy do?
Sertio Oy is an EU Notified Body under IVDR (Regulation EU 2017/746) providing conformity assessment services for In Vitro Diagnostic Medical Devices across Class A sterile, B, C, and D risk classes, including companion diagnostics. The company also operates as a FINAS accredited ISO 13485 certification body, issuing quality management system certifications for IVD manufacturers, IVD operators, and sterilization service providers. Services include technical documentation review, QMS audits (Stage 1 and Stage 2), certificate issuance with up to 5-year validity, annual surveillance audits, and Article 16 QMS assessments for importers and distributors.
Is Sertio Oy a public or private company?
Sertio Oy is a private company. It is classified as corporate owned and is currently operating.
When was Sertio Oy founded?
Sertio Oy was founded in 2021. It employs 1 to 10 people.
Where is Sertio Oy based?
Sertio Oy is headquartered in Tampere, Finland, in the Europe region.
How does Sertio Oy make money?
Two revenue lines are on record. IVDR Notified Body Certification Services are the primary driver. The others are ISO 13485 Certification Services.
Who are Sertio Oy's main competitors?
Direct peers on record are SGS, TÜV Rheinland, TÜV SÜD, Intertek, DEKRA and BSI Group. Broad incumbents are Bureau Veritas, Kiwa Oy and UL Solutions. Eurofins Scientific is listed as an emerging player.
Does Sertio Oy have an API?
No public API is recorded for Sertio Oy.
What industry is Sertio Oy in?
Sertio Oy's product category is Medical Device Certification Services. Its primary akta.pro industry code is HLAJADAD, In Vitro Diagnostics (IVD) Regulators, with a secondary code of HLAGAKAL, Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control). Its NAICS code is 541380 and its SIC code is 8734.