Use-Lab GmbH
★★★★★
4.9
/ 5
•
15 reviews
Use-Lab GmbH specializes in Usability Engineering for medical devices, offering expert consulting, user research, and comprehensive documentation to enhance product safety and user-friendliness.
Use-Lab GmbH is a dedicated Usability Engineering service provider with over 20 years of experience, focusing on the medical device industry. They offer professional and individual consulting, design services, and comprehensive documentation to manufacturers of medical products, laboratory equipment, and in-vitro diagnostics. Their services are crucial for ensuring that medical devices are not only user-friendly and intuitive but also safe for patients. By understanding the end-users' needs through rigorous User Research and employing scientifically validated methods, Use-Lab helps clients develop and optimize products. This includes formative and summative usability studies, focusing on everything from graphical interfaces to user manuals. Use-Lab is particularly adept at creating compliant Usability Documentation, including Use Scenarios, Use Specifications, and the complete Usability Engineering File, adhering to standards like MDR, IEC 62366, and ISO 14971. They also assist with FDA submissions and risk management files, ensuring products meet regulatory requirements and minimize the risk of user errors, ultimately contributing to patient safety and product quality.
About
**Who they are**
Use-Lab GmbH is a specialized provider of Usability Engineering services, particularly for medical devices, with extensive experience in regulatory compliance.
**Expertise & scope**
* Expert consulting for medical device usability, focusing on product safety and user-friendliness.
* Conducts usability evaluations to identify product weaknesses and ensure users can achieve their goals intuitively.
* Specializes in creating and reviewing comprehensive usability documentation, including Use Scenarios, Use Specifications, and Usability Engineering Files.
* Experienced in adhering to relevant standards and regulations such as MDR, IEC 62366, ISO 14971, and ISO 13485.
* Offers user research, including formative and summative usability studies, and can focus on specific product components or the system as a whole.
* Provides express consulting, remote testing, and post-market surveillance services.
* Actively participates in national and international standardization committees, contributing to the development of relevant guidelines.
**Reputation / proof points**
* Over 20 years of experience in medical device approval and documentation processes.
Use-Lab GmbH is a specialized provider of Usability Engineering services, particularly for medical devices, with extensive experience in regulatory compliance.
**Expertise & scope**
* Expert consulting for medical device usability, focusing on product safety and user-friendliness.
* Conducts usability evaluations to identify product weaknesses and ensure users can achieve their goals intuitively.
* Specializes in creating and reviewing comprehensive usability documentation, including Use Scenarios, Use Specifications, and Usability Engineering Files.
* Experienced in adhering to relevant standards and regulations such as MDR, IEC 62366, ISO 14971, and ISO 13485.
* Offers user research, including formative and summative usability studies, and can focus on specific product components or the system as a whole.
* Provides express consulting, remote testing, and post-market surveillance services.
* Actively participates in national and international standardization committees, contributing to the development of relevant guidelines.
**Reputation / proof points**
* Over 20 years of experience in medical device approval and documentation processes.
Additional information
Use-Lab GmbH emphasizes a collaborative approach, particularly for complex usability challenges that extend beyond standard textbook methods. They are adept at conducting usability studies within the US regulatory environment. Their services are designed to ensure products are not only safe and intuitive but also meet user expectations and regulatory requirements. Buyers can expect a partner with deep involvement in standardization bodies, ensuring their documentation and evaluations are aligned with current and evolving industry best practices. Engagement typically involves close consultation to tailor studies and documentation to specific product needs.
Key Highlights
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Specializes in Usability Engineering for medical devices, ensuring product safety and user-friendliness.
Source
“Use-Lab GmbH specializes in Usability Engineering for medical devices, offering expert consulting, user research, and comprehensive documentation to enhance product safety and user-friendliness.”
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Experienced in creating and reviewing comprehensive usability documentation aligned with MDR, IEC 62366, ISO 14971, and ISO 13485.
Source
“Dabei berücksichtigen wir die relevanten Gesetze und Standards wie z.B. MDR, IEC 62366, ISO 14971 und ISO 13485.”
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Possesses over 20 years of experience in medical device approval and documentation.
Source
“Durch die mehr als 20 jährige Erfahrung im Bereich der Zulassung von Medizinprodukten und der Dokumentation der zugehörigen Prozesse...”
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Actively participates in national and international standardization committees, contributing to industry guidelines.
Source
“Da unser Geschäftsführer Torsten Gruchmann ebenfalls ein aktives Mitglied dieses Gremiums ist, freut er sich, diese Einblicke von anderen Ausschussmitgliedern mit der Medizintechnik-Branche zu teilen.”
Certifications & Trust Signals
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Over 20 years of experience in medical device approval and documentation.
Source
“Durch die mehr als 20 jährige Erfahrung im Bereich der Zulassung von Medizinprodukten und der Dokumentation der zugehörigen Prozesse...”
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Active participation in national and international standardization bodies.
Source
“Da unser Geschäftsführer Torsten Gruchmann ebenfalls ein aktives Mitglied dieses Gremiums ist...”
Buyer Snapshot
Best for
- Medical device manufacturers seeking regulatory compliance for usability.
- Companies needing expert support in usability documentation and testing.
- Developers of combination products requiring specialized HFE expertise.
How engagement typically works
- Collaborative consulting
- Solution-oriented partnership
- Tailored study design
Typical deliverables
- Usability Evaluation Reports
- Usability Engineering Files
- Use Scenarios & Specifications
- User Research Findings
- Regulatory Compliance Documentation
Good to know
- Best when requiring in-depth analysis of product safety and user-friendliness.
- Best when needing to comply with specific medical device regulations (MDR, IEC 62366, ISO 14971).
HQ:
DE
Languages:
English
Timezones:
UTC+1
Status:
listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Germany, China, France, Netherlands, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Usability Study Types Offered:
Formative study, Summative study
Services Offered:
User interface evaluation, Instructions evaluation, Risk analysis, Other
User Types Supported:
Professional healthcare
Use Environments Supported:
Professional healthcare
Standards Supported:
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, ISO 14971, Other
Has Participant Recruitment:
Yes
Has Usability Lab:
Yes
Has Remote Testing:
Yes
Rush Available:
No
Nda Support:
Yes
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study, Both
Services Offered
Risk analysis, User interface evaluation, Instructions evaluation, Validation testing, Express-Consulting, User Research, Usability Evaluation, Usability Dokumentation, Begleitinformationen, Marketing Claims, Design, Sustainability, Adherence Study, Remote Testing, Training, Post-Market Surveillance, Rekrutierung, Räume
Standards Supported
IEC 62366-1, IEC 62366-2, ISO 14971, ISO 13485, MDR
User Types Supported
Lay user, Professional healthcare, Both
Use Environments Supported
Home healthcare, Professional healthcare, Both
Lead Time Band
Start in 0-2 weeks
Quote SLA
24-48 hours
Minimum Project Size
Custom
Pricing Model
Custom
