QUNIQUE

What QUNIQUE does

QUNIQUE is a privately held Swiss regulatory and quality management consultancy founded in May 2017 by Angelina Hakim, specializing in the medical device and in-vitro diagnostic (IVD) industries. The firm serves three primary customer verticals — medical device manufacturers, IVD manufacturers, and distributors of both — helping clients navigate compliance with EU MDR 2017/745, EU IVDR 2017/746, Swiss MedDO and IvDO, ISO 13485:2016, ISO 14155, MDSAP, and US FDA 21 CFR Part 820. Its core offerings are human-delivered professional services: regulatory affairs consulting (technical documentation, clinical evaluation, submissions), quality management consulting (audits, mock audits, supplier audits), project management for MDR/IVDR remediation, leadership coaching, and in-house/public training seminars. These are complemented by a recurring Authorized Representative service delivered through two legal entities — QUNIQUE AG in Wohlen, Switzerland (CHE-230.350.138) and QUNIQUE GmbH in Hamburg, Germany — which collectively enable non-EU and non-Swiss manufacturers to access both the EU and Swiss markets.

QUNIQUE's business model combines professional services revenue with a growing productized component. Consulting, AR retainers, and training are billed as professional services engagements; alongside these, the firm sells downloadable QMS document templates, SOPs, gap assessment reports, and Notified Body checklists through a self-serve e-commerce shop, with individual packages priced €50–€1,050 and full bundles at €5,899.98 and €10,000. A 10% commission affiliate program across 31 countries extends distribution of these products through third-party partners. The firm holds ISO 13485:2016 certification through IQNet/SQS (valid 2024–2027), operates a training facility in Wohlen, and reaches customers through direct B2B sales, content marketing, LinkedIn, YouTube, Facebook, and Twitter. In November 2025, Healthcare Holding Schweiz AG (backed by KKR) acquired a strategic stake in QUNIQUE GmbH, providing first external institutional capital and a platform for further MedTech vertical expansion while QUNIQUE retains operational independence.

Name

QUNIQUE

Legal name

QUNIQUE AG

Website

https://quniquegroup.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

QUNIQUE is a Swiss-founded regulatory and quality management consultancy serving medical device and IVD manufacturers and distributors with EU MDR/IVDR, Swiss MedDO/IvDO, and ISO 13485 compliance services, supplemented by productized QMS document templates and Authorized Representative services across Switzerland and Germany.

Ownership category

akta.pro rank

Headquarters

HQ city

Wohlen

HQ country

Switzerland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting Services: Consultancy services in regulatory affairs, quality management, training, and leadership provided to medical device and IVD manufacturers. Services include gap analysis, technical documentation compilation, clinical evaluation, and regulatory submission support.
2. Document Templates and Tools: Sale of pre-built QMS document templates, SOPs, checklists, and gap assessment reports through the online shop. Individual tools range from €50-€1,050, bundles from €99-€10,000.
3. Training and Seminars: In-house and public training programs on regulatory topics including MDR, IVDR, ISO 13485, MDSAP, and audit preparation. Also offers online and onsite training delivery.
4. Authorized Representative Services: Provides Authorized Representative services for medical and IVD device manufacturers for Switzerland through QUNIQUE SWITZERLAND and for the EU through QUNIQUE GERMANY.
5. Affiliate Referrals: 10% commission on product purchases made through affiliate referral links, with 120-day cookie duration for tracking conversions.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

QUNIQUE is a consulting organisation that provides regulatory affairs, quality management, project management, leadership coaching, and training services to medical device and in-vitro diagnostic manufacturers, complemented by a portfolio of downloadable QMS document templates, SOPs, checklists, and gap assessment reports sold through its online shop. It also acts as EU and Swiss Authorized Representative for non-EU/non-Swiss device manufacturers via its Swiss (QUNIQUE AG, Wohlen) and German (QUNIQUE GmbH, Hamburg) entities.

Product overview

QUNIQUE is a medical technology consulting firm founded in 2017, providing regulatory and quality management services to the medical device and in-vitro diagnostic industries. The company operates as a services-based organization offering core consulting products including Quality Management Consulting, Regulatory Affairs Consulting, Project Management Consulting, Leadership Coaching, Training & Seminars, and Authorized Representative & Importer Services. These services are complemented by a portfolio of downloadable document packages and tools including QMS (Distributors) Document Requirements Package, QMS (Distributors) Resources Requirements Package, QMS (Distributors) Purchasing Package, QMS (Distributors) Traceability Requirements Package, and 18+ additional specialized QMS packages for distributors. The company also offers standalone tools such as MDR Notified Bodies Checklist, IVDR Notified Bodies Checklist, Swiss MedDO vs. EU MDR Gap Assessment Report, and Swiss IvDO vs. EU IVDR Gap Assessment Report. Additional offerings include seminar room rental in Switzerland and an affiliate marketing program. The company is ISO 13485 certified and operates offices in Switzerland (Wohlen) and Germany (Hamburg).

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Management Consulting Consulting service for medical device and IVD companies providing audit preparation, mock audits, internal audits, supplier audits, and lead-auditor training; coordinates with regulatory authorities and notified bodies.
• Regulatory Affairs Consulting End-to-end regulatory guidance for market entry of medical devices and IVDs, including initial planning, technical documentation compilation, regulatory submissions, gap assessments, clinical / performance strategy review, and post-market reports (SSCP, PMCF, PSUR).
• Project Management Consulting Project leadership and support for initiating, planning, and executing regulatory projects including MDR/IVDR remediation programs and change management; provided as full leadership or alongside in-house project managers.
• Leadership Coaching Career growth and personal development coaching delivered by senior mentors with global MedTech management experience to junior, middle, and executive managers in the medical device and IVD industry.
• Trainings and Seminars In-house and public training covering MDSAP, EU MDR, EU IVDR, EU Clinical Evaluation, Post-Market Surveillance, Person Responsible for Regulatory Compliance, ISO 13485, and ISO 14155; delivered onsite, online, or as public events with international speakers.
• Authorized Representative & Importer Services EU and Swiss Authorized Representative services for non-EU and non-Swiss medical device and IVD manufacturers, including technical documentation review, competent authority registration, and ongoing regulatory compliance support through QUNIQUE Germany and QUNIQUE Switzerland.
• QMS Distributors Documentation Suite (SOPs, Checklists, Bundles, Gap Assessments, Notified Body Checklists) A portfolio of downloadable QMS document packages, SOPs, and tools for medical device and IVD distributors compliant with ISO 13485:2016, EU MDR 2017/745, EU IVDR 2017/746, and GDPR; sold individually (€50–€1,050), as a complete bundle of 22 packages (€5,899.98), or as a bundle with additional consulting services (€10,000). Includes MDR/IVDR Notified Bodies Checklists (€59 each / €99 bundle) and Swiss MedDO vs. EU MDR and Swiss IvDO vs. EU IVDR Gap Assessment Reports (€899 each / €1,499 bundle).
• Seminar Room Rental Fully equipped meeting room in Wohlen, Switzerland available for team and management meetings, with or without catering and additional meeting equipment.

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature3 records

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• NAMSA: Medical device-focused CRO and consulting firm offering regulatory, quality, clinical, and laboratory services. Operates a much broader MedTech stack but competes for the same manufacturer clients on regulatory affairs and QMS.
• NSF International: Global public health and safety organisation with a Health Sciences division providing MedTech regulatory consulting, training, and QMS support. Comparable in training and consulting offerings though much larger.
• BSI Group: Standards body and certification firm running a Health & Medical Devices practice that includes ISO 13485 certification, MDR/IVDR training, and regulatory consulting. Competes for the same compliance budgets.
• TÜV SÜD: Global testing, inspection, certification, and training body operating a dedicated MedTech service line (notified body activities, ISO 13485 audits, regulatory consulting). Much larger, but overlaps with QUNIQUE on QMS consulting and training.
• DEKRA: Global testing, inspection, and certification organisation with MedTech product testing and certification services. A broad incumbent whose certification offerings intersect QUNIQUE's audit-preparation consulting.

Direct peers

• Medidee Services SA: Switzerland-based MedTech regulatory and quality management consultancy. Nearly identical service offering (regulatory affairs, QMS, clinical evaluation, AR) and a direct geographic and product competitor to QUNIQUE in CH and EU markets.
• Qserve Group: Netherlands-based MedTech and IVD regulatory/quality consulting firm offering strategy, clinical evaluation, QMS, and AR services. Operates in the same regulatory niche and competes for the same EU/EEA manufacturer clients.
• RQM+: US-headquartered MedTech regulatory and quality consulting firm with EU presence. Provides QMS, regulatory affairs, clinical, and post-market services — a direct comparable for QUNIQUE's core consulting stack.

Emerging players

• MedPass International: European Authorized Representative and regulatory consultancy for medical device and IVD manufacturers. Direct overlap with QUNIQUE's German AR service line and a comparable specialised competitor.
• ClariMed: US-based MedTech regulatory affairs and quality systems consultancy offering services similar to QUNIQUE's core consulting stack. Smaller scale but a direct niche competitor for AR and QMS work.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/QUNIQUE_GmbH
• YouTubeyoutube.com/channel/UCFXbi-FwnhTSoIA-BKUNXFw
• Facebookfacebook.com/QUNIQUEGmbH
• LinkedInlinkedin.com/company/11146390

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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 QUNIQUE