SEMH

What SEMH does

SEMH (Stichting Erkenning Medische Hulpmiddelenzorg) is an independent, impartial Dutch non-profit certification institute founded in 1995 through collaboration between health insurers and industry associations. Its core function is to develop, maintain, and enforce quality standards for medical device providers (hulpmiddelenzorgbedrijven) across the Netherlands, covering orthoses and prostheses, orthopedic footwear, therapeutic elastic compression stockings, mammacare, hearing aids, hair systems, podology, diabetes/continence/stoma/wound care, and custom-made support soles and lying ortheses. The organization operates as a portfolio of sector-specific recognition schemes — each with its own audit criteria — supported by a centralized public register searchable by device type and postcode, professional registers for triage audiologists and hair specialists, and an accredited continuing education system.

The underlying "platform" is primarily procedural and standards-based rather than software-led: recognition requires passing an initial audit and ongoing on-site and written reassessments conducted by independent trained assessors, with certificates tied to specific device categories and approved care locations. SEMH's technology footprint includes the public online register, encrypted document handling for assessment reports, and a synchronization link with Vektis's AGB (Algemeen Gegevensbeheer) healthcare provider register to maintain consistent qualification codes. SEMH has itself been ISO 9001 certified since 8 May 2006, and the organization is governed by a Bestuur, Raad van Advies councils (one per device sector), and a Toetsingscommissie that makes final certification decisions.

SEMH's business model is fee-for-certification on a recurring subscription basis: medical device companies pay recognition/certification fees (detailed in a published Tarievenblad) plus annual contributions to maintain recognition. A supplementary voluntary sustainability recognition for hair system companies carries an additional EUR 50 per year. The go-to-market is sales-led via direct engagement — companies seeking recognition contact SEMH to initiate the process — and the value proposition is anchored on insurer recognition of the SEMH quality mark, consumer discoverability through the public register, and the quasi-regulatory standing SEMH holds within the Dutch medical device provision ecosystem. The Dutch medical device provision sector represents 3.5% of total basic insurance package costs under the Zorgverzekeringswet, defining the addressable market.

Name

SEMH

Legal name

SEMH - Stichting Erkenning Medische Hulpmiddelenzorg

Website

https://semh.info

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

1–10 employees

Short description

SEMH is an independent Dutch non-profit certification institute that develops, maintains, and enforces quality standards for medical device providers across the Netherlands. It certifies companies in orthotics, audiology, compression therapy, mammacare, hair systems, podology, and related sub-sectors through sector-specific recognition schemes.

Ownership category

akta.pro rank

Product category

Medical Device Quality Certification

akta.pro primary industry

GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE)

akta.pro secondary industries

Manufacturing Quality, GMP Inspections & Compliance (HLAJADAG), Provider Network, Credentialing & Contracting Support (BPAAAFAI)

Keywords

• Medical device certification
• Quality recognition schemes
• Healthcare quality assurance
• Medical aids compliance
• ISO certification services

Headquarters

HQ city

Alphen Aan Den Rijn

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Recognition/Certification Fees: Medical device companies pay fees for recognition and certification. Annual contributions are required for recognition maintenance. The organization publishes a fee schedule (Tarievenblad) detailing costs for various certification services.
2. Sustainability Recognition Fees: Additional voluntary sustainability recognition for hair system companies costs EUR 50 per year, with examination costs slightly higher due to additional time investment of 1-2 hours.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

SEMH develops, maintains, and enforces sector-specific quality recognition schemes that certify medical device care providers in the Netherlands — spanning hearing aids, orthoses/prostheses/orthopedic shoes, therapeutic elastic compression stockings, mammacare, hairpieces, podology, diabetes/continence/stoma/wound care, and custom-made insoles and sleeping orthoses. Companies undergo initial audits and ongoing reassessments by independent assessors, pay annual recognition fees, and are listed in a public register that healthcare consumers use to locate certified suppliers.

Product overview

SEMH (Stichting Erkenning Medische Hulpmiddelenzorg) is an independent, impartial Dutch certification institute that develops, maintains, and enforces quality standards for medical device providers across the Netherlands. It is not a single-product company but an umbrella platform offering a portfolio of sector-specific certification schemes — each covering a distinct category of medical devices and associated professional services. The portfolio includes recognition schemes for: audiologists (fixed and home-based), therapeutic elastic compression stockings (TEK), orthopedic devices (integrated OIM/OSB scheme), mammacare, hairpieces/wigs (HWK), diabetes/continence/stoma/wound care (DISW — pending split into four separate schemes), podology, custom-made insoles (EBS scope), custom-made sleeping orthoses (EBS scope), and hairpiece sustainability. Supporting the recognition system are audit and assessment services (toetsingen), professional registers for audiologists and hair specialists, and an accredited continuing education system. Companies seeking SEMH recognition must pass an initial audit and undergo regular on-site and written reassessments, with certificates tied to the specific device category and valid only for approved care locations. SEMH also maintains a public register allowing consumers to locate certified providers by device type and postcode.

Differentiator

Problem solved

Functional benefit

Products and services

• Auditieve Hulpmiddelen (Audiologists) Certification Scheme Quality recognition scheme covering hearing aid dispensing businesses, with separate tracks for fixed audiology locations and home-based audiologists.
• Therapeutisch Elastische Kousen (TEK) Certification Scheme Quality recognition scheme for therapeutic elastic compression stocking providers, requiring products to be listed on the Lijst van Bernink register.
• Orthopedische Hulpmiddelenzorg Certification Scheme Unified quality recognition scheme for orthopedic device providers, covering orthoses, prostheses, custom-made orthotics, and orthopedic footwear — integrating the formerly separate OIM and OSB schemes.
• Mammacare Certification Scheme Quality recognition scheme for breast prosthesis and mammacare providers, covering prosthetics and post-surgery care products.
• Haarwerken (Hairpieces/Wigs) Certification Scheme Quality recognition scheme for medical hairpiece providers, including a voluntary sustainability recognition track and a professional hair specialist register.
• DISW (Diabetes, Incontinence, Stoma, Wound Care) Certification Scheme Quality recognition scheme covering diabetes supplies, continence products, stoma materials, and wound dressings; scheduled for future split into four separate recognition schemes.
• Podologiebedrijven (Podology) Certification Scheme Quality recognition scheme for podology businesses, requiring professional registration in the KWOT quality register.
• EBS Custom-Made Insoles (Steunzolen) Certification Scope-based quality recognition for businesses supplying custom-made foot insoles.
• EBS Custom-Made Sleeping Orthoses (Ligortheses) Certification Scope-based quality recognition for businesses supplying custom-made lying/sleeping orthoses.
• Duurzaamheid HWK (Hairpiece Sustainability) Certification Scheme Voluntary sustainability certification scheme for hairpiece businesses, covering environmental impact and energy use, in addition to standard HWK recognition. Costs EUR 50 per year.
• Klachtencommissies (Complaints Committees) Certification Scheme Quality recognition scheme for independent complaints committees that handle patient complaints against SEMH-recognized medical device providers.
• Assessment / Audit Services (Toetsingen) On-site audits and remote document reviews conducted by independent, trained assessors to verify that medical device providers meet SEMH recognition requirements on an ongoing basis.
• Professional Registers (Beroepsregisters) SEMH-maintained personal registers for triage audiologists and hair specialists who meet competency and continuing education requirements.
• Accredited Training Activities (Geaccrediteerde Scholingsactiviteiten) SEMH-accredited continuing education courses across compression therapy, hairpieces, mammacare, orthopedics, and podology, with points tracked for professional recertification.
• General Requirements (Algemene Eisen) Baseline quality requirements that every SEMH-recognized medical device provider must satisfy, covering staff competence, facility standards, client handling, and information provision.

Named customers1 record

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

15 partnerships are on record, tiered core.

• VektiscoreTechnology or Integration · 1 January 2023Vektis maintains the AGB (Algemeen Gegevensbeheer) register for healthcare providers. SEMH is synchronizing its recognition register with the Vektis AGB register to ensure consistent qualification codes for certified companies.
• FMed (Federatie Medisch Speciaalzaken)coreStrategic or Co-development Partner · 1 January 1995FMed represents medical specialty businesses and participates in SEMH advisory councils. Representatives from FMed sit on the Council of Advice for DISW (Diabetes, Incontinence, Stoma and Wound care).
• StomaverenigingcoreStrategic or Co-development Partner · 1 January 1995Patient organization representing stoma patients participates in SEMH advisory councils to represent consumer interests in quality standards development.
• V&VN (Verpleegkundigen & Verzorgenden Nederland)coreStrategic or Co-development Partner · 1 January 1995Nursing organization participates in SEMH advisory councils for quality standards development.
• HSBN (Haarwerk Specialisten Branchevereniging Nederland)coreStrategic or Co-development Partner · 1 January 1995Branch association for hair system specialists collaborates with SEMH on advisory councils and supports the hair specialist register. Provides accreditation support for training activities.
• NVMCZ (Nederlandse Vereniging voor MammaCare zorg)coreStrategic or Co-development Partner · 1 January 1995Professional association for mammacare supports SEMH accreditation of training activities and participates in advisory councils.
• NVOS-OrthobandacoreStrategic or Co-development Partner · 1 January 1995Branch association for orthopaedic businesses participates in SEMH advisory councils for orthopaedic standards development.
• SOHN (Stichting Orthopedisch Hoofdbedrijf Nederland)coreStrategic or Co-development Partner · 1 January 1995Foundation representing orthopaedic businesses participates in SEMH advisory councils and standards development.
• NBOT (Nederlandse Beroepsvereniging voor Orthopedisch Technologen)coreStrategic or Co-development Partner · 1 January 1995Professional association for orthopaedic technologists participates in SEMH advisory councils for orthopaedic standards.
• NLNet (Lymfoedeem Netwerk Nederland)coreStrategic or Co-development Partner · 1 January 1995Patient network for lymphoedema represents consumer interests in compression therapy advisory councils.
• AudiNedcoreStrategic or Co-development Partner · 1 January 1995Professional association for audiologists collaborates with SEMH on hearing care standards and participates in advisory councils.
• BVN (Borstkanker Vereniging Nederland)coreStrategic or Co-development Partner · 1 January 1995Breast cancer patient association represents consumer interests in mammacare advisory councils.
• Alopecia VerenigingcoreStrategic or Co-development Partner · 1 January 1995Patient association for alopecia represents consumer interests in hair system advisory councils.
• Vereniging van Mensen met BrandwondencoreStrategic or Co-development Partner · 1 January 1995Patient association representing burn victims participates in hair system advisory councils.
• Zorgverzekeraars Nederland (ZN)coreStrategic or Co-development Partner · 1 January 1995Dutch Health Insurers association participates in SEMH advisory councils and requested development of sustainability requirements for medical device companies.

Scale indicators3 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• TÜV Rheinland: TÜV Rheinland is another leading German-rooted global TIC company with healthcare and medical device certification services. It is comparable to SEMH in offering quality and compliance audits for medical device manufacturers, but at significantly larger international scale.
• BSI Group: BSI Group is a UK-headquartered standards and certification body with strong medical device and ISO 9001/QMS offerings. It is comparable to SEMH in its certification and quality management services for healthcare providers, though at far larger international scale.
• DNV (Healthcare): DNV is a global certification body with a dedicated healthcare division offering quality and accreditation services to hospitals and medical device providers. It shares SEMH's mission of certifying healthcare quality and compliance, but at a much larger global scale.
• LRQA: LRQA is a global assurance and certification firm with ISO and medical device quality management certification services. It is comparable to SEMH in auditing and certifying quality systems for healthcare and medical device organizations, though from a much broader international portfolio.
• TÜV SÜD: TÜV SÜD is a major global certification body with an extensive medical device and healthcare compliance practice. It serves as a notified body under EU MDR, directly competing with SEMH's quality audit and supplier qualification role, though from a much larger, multi-sector base.
• DEKRA Certification: DEKRA is a global certification body headquartered in Germany with a significant medical device and healthcare certification practice. It overlaps with SEMH's quality and compliance services for medical device manufacturers, but operates at much broader scale and across multiple industries.
• Bureau Veritas: Bureau Veritas is a global testing, inspection, and certification firm with a healthcare and medical device compliance practice. It is comparable to SEMH in providing quality audits for medical device manufacturers, but operates across many sectors and geographies.

Others

• Dutch Healthcare Inspectorate (IGJ): The IGJ is the Dutch Health and Youth Care Inspectorate responsible for overseeing quality and safety in Dutch healthcare. While not a direct competitor, it is a stakeholder in the same regulatory ecosystem as SEMH and plays a complementary role in healthcare quality oversight in the Netherlands.

Regional players

• HKZ (Harmonisatie Kwaliteitsbeoordeling Zorginstelling): HKZ is a Dutch certification scheme specifically for healthcare institutions, focused on quality assurance for healthcare providers. It is comparable to SEMH as a Dutch quality certification body in healthcare, though it focuses on broader healthcare institutions rather than specialized medical device providers.

Direct peers

• Kiwa: Kiwa is a leading Dutch-based TIC (testing, inspection, certification) company operating globally with strong healthcare and medical device certification offerings. It is the most direct peer to SEMH in scope, geography, and customer base, though it is far larger and operates across many industries.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SEMH_nederland
• LinkedInlinkedin.com/company/semh

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

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 SEMH