Qarad Suisse S.A.
Qarad is a specialized consulting firm for the IVD and Medical Device industry, offering expertise in Regulatory Affairs and Quality Systems. They are part of the QbD Group, providing comprehensive product lifecycle support.
Qarad is a consulting company with over 30 years of experience, specializing in Regulatory Affairs and Quality Systems for the In Vitro Diagnostics (IVD) and Medical Device (MD) industries. They offer a comprehensive suite of services including CE Marking, Quality Systems, Risk Management, and e-Labeling (eIFU) solutions, leveraging new technologies to simplify processes for their clients. As an ISO 13485:2016 and ISO 27001:2022 certified company, Qarad ensures high standards in quality management and information security. Their services cover the sales and provision of consulting, training, authorized representative functions, performance evaluation, and e-labeling for the medical device sector. Qarad is a proud member of the QbD Group, a multinational organization with over 600 employees that supports life science companies globally throughout the entire product lifecycle, from initial idea to patient. This affiliation allows Qarad to offer extended services in regulatory affairs, clinical trials, qualification & validation, quality assurance, lab services, software solutions, and business communications, backed by a global network of expertise.
About
**Who they are**
Qarad Suisse S.A. is a specialized consulting firm with over 30 years of experience in the IVD and Medical Device industry, focusing on Regulatory Affairs and Quality Systems. They are part of the QbD Group, offering comprehensive support throughout the product lifecycle.
**Expertise & scope**
* Expertise in IVD and Medical Device regulations.
* Services include consulting, training, authorized representative functions, performance evaluation, and e-labeling.
* Development of eIFU (electronic Instructions for Use) services for digital distribution of technical documentation.
* Focus on compliance and risk management.
* Consultants possess in-depth knowledge in areas such as immunoassays, next-generation sequencing, PCR tests, and flow cytometry.
**Reputation / proof points**
* ISO 13485:2016 certified for quality management systems.
* ISO 27001 certified.
* Experienced in the IVD and MD field since 1986.
Qarad Suisse S.A. is a specialized consulting firm with over 30 years of experience in the IVD and Medical Device industry, focusing on Regulatory Affairs and Quality Systems. They are part of the QbD Group, offering comprehensive support throughout the product lifecycle.
**Expertise & scope**
* Expertise in IVD and Medical Device regulations.
* Services include consulting, training, authorized representative functions, performance evaluation, and e-labeling.
* Development of eIFU (electronic Instructions for Use) services for digital distribution of technical documentation.
* Focus on compliance and risk management.
* Consultants possess in-depth knowledge in areas such as immunoassays, next-generation sequencing, PCR tests, and flow cytometry.
**Reputation / proof points**
* ISO 13485:2016 certified for quality management systems.
* ISO 27001 certified.
* Experienced in the IVD and MD field since 1986.
Additional information
Qarad's services extend to providing a single supplier solution for eIFU, developed by regulatory experts with a strong emphasis on compliance and risk management. Their certificate for ISO 13485:2016 specifically covers "The sales and provision of consulting, training, authorized representative, performance evaluation and e-labeling services for the medical devices industry." They leverage a wide network of selected professionals and organizations to ensure high-quality service delivery.
Key Highlights
-
Specialized consulting for the IVD and Medical Device industry.
Source
“Qarad is a consulting company, specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry.”
-
ISO 13485:2016 and ISO 27001 certified.
Source
“Qarad is an ISO 13485:2016 certified company. ... ISO 27001 Certified”
-
Over 30 years of experience in the IVD and MD field since 1986.
Source
“Experienced in the IVD and MD field since 1986; More than 30 years experience in IVD”
-
Offers eIFU services for digital distribution of technical documentation.
Source
“also resulted in the development of our eIFU services. Our solution helps manufacturers to distribute their technical documentation via a digital platform.”
Certifications & Trust Signals
-
ISO 13485:2016 certified for quality management systems.
Source
“Qarad is an ISO 13485:2016 certified company. ISO 13485:2016 is the standard for a quality management system focusing on the ability to provide products and services that meet all regulatory requirements for medical devices.”
-
ISO 27001 certified.
Source
“ISO 27001 Certified”
-
Part of the QbD Group.
Source
“Qarad is part of QbD Group”
Buyer Snapshot
Best for
- Manufacturers in the IVD and Medical Device industry seeking regulatory and quality system support.
- Companies needing an Authorized Representative in Switzerland.
- Businesses looking for expertise in eIFU solutions.
How engagement typically works
- Consultative approach based on extensive industry experience.
- Leveraging a network of professionals for comprehensive service.
- Focus on compliance and risk management.
Typical deliverables
- Regulatory Affairs and Quality System consulting.
- Authorized Representative services.
- IVD Technical Documentation support.
- Post-Market Surveillance.
- Performance Study Documentation.
- eIFU services.
Good to know
- Best when requiring specialized knowledge in IVD and Medical Device regulations.
HQ:
Lausanne, 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:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
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
Vigilance Contact Support:
Yes
Labeling Support:
Yes
Swiss Local Contact:
Yes
Swiss Entity Canton Or Region:
Zug
Can Be Named On Label:
Yes
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Intake → mandate agreement → labeling/documentation check → Swiss workflows live
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Not explicitly stated, but implied support for IVDs and Medical Devices.
Supports MDR
true
Supports IVDR
true
Labeling Support
true
Swiss Local Contact
true
Vigilance Contact Support
true
Can Be Named On Label
true
