inteQRA is your experienced partner for management systems and regulatory affairs in medtech. We support you hands-on, pragmatically and competently in the following areas:
Management systems:
- Management systems tailored to customer needs according to ISO 13485 / ISO 14001 / FDA QSR
- Conducting internal audits and supplier audits
QM/UM/RA support:
- Outsourcing of quality and environmental management functions (PRRC, QMB, UMB)
- Support with CAPAs / remediation of audit non-conformities
- Conducting PMS and vigilance activities
- Evaluation and verification of AI tools for regulatory knowledge management
Medical devices:
- Creation of technical documentation according to MDR and 510(k)
- Support with risk management, validation and biocompatibility
Company Details
- Employees
- 1
- Founded
- -
- Address
- Besslerweg 8, Altdorf,uri 6460,switzerland
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- http://www.inteqra.ch
- Keywords
- ISO 13485, ISO 14001, FDA QSR, Audits, ISO 14971, Risikomanagement, PRRC, MDR, Technische Dokumentation, Designvalidierung, Prozessvalidierung, sterile Verpackungssysteme, Biokompatibilität, ISO 10993, Post-Market Surveillance, Vigilanz, Regulatory KI.
- HQ
- Altdorf, Uri
Inteqra Gmbh Questions
Inteqra Gmbh's website is http://www.inteqra.ch
Inteqra Gmbh's LinkedIn profile is https://ch.linkedin.com/company/inteqra
Inteqra Gmbh has
1 employees.
View email and phone details for 1
employees at Inteqra Gmbh.
Inteqra Gmbh's industry is
Medical Equipment Manufacturing
Inteqra Gmbh's top competitors are
D.o. Research,
Kahlity Gmbh,
Roder Engineering Ag,
Smdc Swiss Medical Device Consulting Gmbh,
Inteqra Ab,
Forcentis Ag,
Perina Advanced Quality Engineering,
Keyros Medica (Ex Revinax),
Actum Digital,
Euphalt Ag.
Inteqra Gmbh's categories are Medical Equipment Manufacturing
Inteqra Gmbh's founding year is 2025
