The core activity of GO FOR Q! GmbH is the provision of services in the field of quality management and approval for manufacturers in the medical technology sector. This includes, in particular, individual consulting and support in the implementation of standards such as ISO 9001, ISO 13485, medical device approval, risk management, and other industry-specific standards.
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Products & services
Industry:Medical Technology Industry
✓ Offered5
Advisory for Quality Management and Approval
Tailored consulting for quality management, medical-device regulatory approval, risk management and domain-specific standards such as ISO 9001, ISO 13485 and EN 60601.
Certification Preparation
Preparation for certifications at a fixed price for ISO 13485, ISO 9001, ISO 14001 and ISO 17025, including complete QMS documentation and implementation.
Quality Management Support
Support ranging from consulting to interim management and troubleshooting, optimisation of QMS organisation as well as supplier management, product release, process validations and PMS/Vigilance.
Audits
System audits, process audits and supplier audits, including preparation, question sets, conducting, reporting, action recommendations and FDA audit support.
Support for Standards and Regulations
Support with MDR updates, GAP analyses, standards and QMS updates, software validations, risk management, development projects as well as clinical studies and evaluations.
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