be-on-Quality

What be-on-Quality does

be-on-Quality is a German boutique consultancy, legally operating as Consultys medical GmbH (with a related be-on-Quality GmbH entity also referenced), headquartered in Reichenschwand with a second office in Lauf an der Pegnitz, Bavaria. Founded in 2017 and led by Managing Director Stefan Bolleininger, the firm provides regulatory affairs and quality management consulting services to medical device manufacturers (MedTech and Lifescience companies) seeking to place products on the European market.

The company delivers four integrated service lines: Quality Management system development and maintenance under EN ISO 13485; Regulatory Compliance services including strategy, technical file preparation, CE marking, and post-market surveillance; Management Systems and Audits covering mock audits, compliance audits, inspection support, and supplier qualification; and Clinical Evaluations and Trials support. The offering spans the full market-access lifecycle from product development through post-market obligations. Underlying capability is human-expert consulting — there is no proprietary software, platform, or AI-driven tooling referenced in the firm's service portfolio.

The business model is a sales-led B2B professional services engagement, delivered directly to medical device clients via phone, email, and website contact. Pricing is quote-based with no public rate cards, indicating project-based or retainer arrangements scoped to client needs. The firm markets through its two corporate websites, a LinkedIn page (consultys-medical), and an Instagram handle (beonquality), with no disclosed customer logos, revenue, funding, or institutional investors. Operationally the firm is small (11-50 employees), privately held, and regionally focused on the DACH/European MedTech market.

Name

be-on-Quality

Legal name

Consultys medical GmbH

Website

https://be-on-quality.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

be-on-Quality (Consultys medical GmbH) is a German boutique consultancy providing ISO 13485 quality management, CE marking, regulatory compliance, and clinical evaluation services to medical device manufacturers across Europe.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro industry

PRIMARYBPAHACAJ

Risk, Compliance & Internal Controls Consulting

Business & Public Services/Professional Services (Legal, Accounting, Consulting)/Management Consulting

SECONDARYHLAGAKAI

Clinical Quality Assurance (GCP QA, TMF/QMS oversight)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

Keywords

• Medical device regulatory consulting
• ISO 13485 quality management
• CE marking compliance services
• Clinical evaluation consulting
• Medical device audit support

Headquarters

HQ city

Reichenschwand

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting Services: Professional consulting services for regulatory compliance, quality management systems, clinical evaluations, and audit preparation for medical device companies. Services are likely project-based or retainer arrangements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

be-on-Quality (Consultys medical GmbH) provides expert consulting services for medical device companies covering all regulatory and quality management issues in medical technology. The company supports clients with ISO 13485 quality management system development, regulatory compliance and CE marking, clinical evaluations and trials, and audit preparation. Services are delivered directly by senior consultants to MedTech and Life Sciences manufacturers placing devices on the European market.

Product overview

be-on-Quality (operated by Consultys medical GmbH) is a consulting services company providing Quality and Regulatory Affairs services for the MedTech and Lifescience industries. The company offers an integrated portfolio of four core service offerings: Quality Management (ISO 13485 compliant), Regulatory Compliance Services (including CE marking), Management Systems and Audits, and Clinical Evaluations and Trials. These services help medical device companies navigate regulatory compliance for placing products on the market.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Management

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Expansion highlights4 records

Direct peers

• Qserve Group: Qserve is a global MedTech-focused regulatory and quality consulting firm headquartered in the Netherlands, offering CE marking, ISO 13485, clinical evaluation, and Notified Body support — directly overlapping be-on-Quality's core services for medical device manufacturers.
• Emergo by UL: Emergo by UL is a global consulting arm of UL专门 advising medical device manufacturers on regulatory strategy, CE marking, ISO 13485, and international market access — directly comparable to be-on-Quality's MedTech RA/QA service portfolio.
• MethodSense: MethodSense is a US-based life sciences regulatory and quality consulting firm with a strong MedTech practice in ISO 13485, EU MDR, and quality systems — a direct competitor in regulatory affairs and QMS implementation services.
• Maetrics: Maetrics is a dedicated medical device regulatory and quality compliance consultancy providing ISO 13485, EU MDR, FDA, and audit services — the closest direct competitor to be-on-Quality in scope and customer segment.
• RQM+: RQM+ (formerly Regulatory Quality & Medical) is a MedTech regulatory, quality, and clinical consulting firm offering CE marking, ISO 13485, and EU MDR transition services to medical device manufacturers — a near-perfect functional overlap with be-on-Quality.
• Key2Compliance: Key2Compliance is a Nordic MedTech regulatory and quality management consultancy offering ISO 13485, CE marking, and clinical evaluation support — competing for the same European medical device manufacturer customer base as be-on-Quality.
• BioExcel Consulting: BioExcel Consulting is a boutique MedTech regulatory and quality consultancy providing CE marking, ISO 13485, and clinical evaluation services — comparable to be-on-Quality in scale, service mix, and target customer profile.

Broad incumbents

• NSF International: NSF International is a global public health and safety organization with a medical device certification and consulting practice (NSF Health Sciences) providing ISO 13485, EU MDR, and regulatory services — a broad incumbent with significant overlap on the quality management certification side.
• TÜV SÜD: TÜV SÜD is a large global testing, inspection, certification, and Notified Body organization with a substantial medical device practice offering CE marking, ISO 13485 certification, and regulatory consulting — a much larger incumbent competing for the same MedTech compliance spend.
• DEKRA: DEKRA is a global testing, inspection, and certification organization with MedTech certification and consulting capabilities — a broad incumbent providing overlapping CE marking and ISO 13485 services as part of a much wider portfolio.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat2 records

Key risks6 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/consultys-medical
• Instagraminstagram.com/beonquality
• Xx.com/be_on_Quality

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 be-on-Quality