The Tao of Excellence

The Tao of Excellence GmbH

The Tao of Excellence GmbH is a Swiss-based consultancy specializing in quality management and regulatory compliance for the medical device industry. They offer expert solutions for MDR, IVDR, and MDSAP certifications, aiming for efficient market access and sustainable business processes.

The Tao of Excellence GmbH, based in Schaffhausen, Switzerland, provides specialist consulting services tailored for the medical devices industry. They focus on ensuring regulatory compliance and market success through expert guidance on MDR, IVDR, and MDSAP certifications. Their services encompass Quality Management Systems (QMS/eQMS), Six Sigma training, Gap Analysis, Clinical Evaluation Reports, audit readiness, data analysis, business intelligence, digitalization, and agile business development. With a proven track record of over 50 audits and extensive experience in quality management within dynamic international companies, The Tao of Excellence GmbH offers solutions designed for safer, faster, and more cost-effective processes. They emphasize a solution-oriented, flexible, and positive approach, leveraging creative and innovative ideas alongside long-term practical experience to meet client objectives. Their team of dedicated experts is committed to providing honest, relevant work, fostering an open, efficient, and respectful environment. They aim to optimize business processes and procedures, secure compliance with medical device regulations, and enable organizations to achieve regulatory and commercial success through productive and cost-effective solutions adapted to evolving market needs.

About

**Who they are**
The Tao of Excellence GmbH is a Swiss-based consultancy specializing in quality management and regulatory compliance for the medical device industry.

**Expertise & scope**
* Expert solutions for MDR, IVDR, and MDSAP certifications.
* Support for regulatory strategy in Europe and MDSAP regions.
* Services include Quality Management System (QMS/eQMS), Six Sigma training, Gap Analysis, Clinical Evaluation Reports, compliance, certification, audit readiness, data analysis, business intelligence, digitalization, agile business development, specialist market insight, and business training.
* Focus on efficient market access and sustainable business processes.

**Reputation / proof points**
* Based in Switzerland.
* Offers services in English, German, and French.

Additional information

The Tao of Excellence emphasizes a solution-oriented, flexible, and positive approach, grounded in honest, straight-to-the-point work. Their ethical values foster an open, efficient, and respectful environment. They aim to find ideal solutions by encouraging out-of-the-box ideas and leveraging long-term practical experience. Client objectives are the basis for defining their success, with a methodology that involves assessing the current situation and taking a step-by-step approach to reach goals.

Key Highlights

  • Specialist consultants for the medical devices industry. Source
    “Specialist consultants for the medical devices industry, with a team of experts based in Switzerland”
  • Expertise in MDR, IVDR, and MDSAP certifications. Source
    “support your regulatory strategy with the MDR (Medical Device Regulation) and IVDR (In Vitro Device Regulation) in Europe and MDSAP (Medical Device Single Audit Program) regions.”
  • Offers a range of services including QMS, Six Sigma training, and data analysis. Source
    “Services in Quality Management System (QMS/eQMS), Six Sigma training, Gap Analysis, Clinical Evaluation Reports, compliance, certification”

Certifications & Trust Signals

  • Based in Switzerland. Source
    “with a team of experts based in Switzerland”

Buyer Snapshot

Best for
  • Medical device companies seeking MDR, IVDR, and MDSAP compliance.
  • Businesses needing support with quality management systems.
  • Firms requiring strategic regulatory guidance in Europe and MDSAP regions.
How engagement typically works
  • Solution-oriented and flexible.
  • Customer-focused, aligning with client objectives.
  • Direct and relevant work approach.
Typical deliverables
  • MDR/IVDR/MDSAP certification support.
  • Quality Management System (QMS/eQMS) implementation.
  • Gap Analysis and audit readiness.
  • Clinical Evaluation Reports.
  • Business development and market insight.
Good to know
  • Best when seeking expert regulatory and quality management support for medical devices.
HQ: Schaffhausen, CH
Languages: English, German, French
Timezones: Europe/Zurich
Status: listed

Services & Capabilities

Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes

Jurisdictions: CH
Countries: CH
Industries: Medical devices, IVD
Portfolio: 6-25
Onboarding time: 3–10 days
Pricing model: Custom pricing
Starting from: CHF 1,800
Included services: Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported: Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact: Yes
Labeling Support: No
Swiss Entity Canton Or Region: Schaffhausen
Can Be Named On Label: No
Vigilance Contact Support: No

Additional ch_rep Details

Device Classes Supported
All device classes supported under MDR/IVDR/MDSAP
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Schaffhausen
Labeling Support
Implied through Swiss regulatory framework guidance
Swiss Local Contact
Yes
Vigilance Contact Support
Implied through regulatory compliance services
Can Be Named On Label
Not explicitly stated, but implied for authorized representatives
Onboarding Steps
Contact for consultation to discuss assistance with regulatory compliance, certification, training, strategic intelligence, and business development.
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