Support Regulatory Affairs
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Regulatories
Each market still requests its specific requirements for registrations of a medical device. Our experience in Europe, North- and South America, Asia as well as the Middle East enables us to support you in an efficient obtaining of the aspired market release.
Each market still requests its specific requirements for registrations of a medical device. Our experience in Europe, North- and South America, Asia as well as the Middle East enables us to support you in an efficient obtaining of the aspired market release.
Services Quality Management MedTech
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Q-Support (65 KB)
Set-up and maintenance of a quality management system according to ISO 13485 / QSR is an indispensable condition to be active in the medtech sector. We support you in all important steps of a (re-)registration or adjustments of your QMS to new requirements and offer comprehensive consulting services.
Set-up and maintenance of a quality management system according to ISO 13485 / QSR is an indispensable condition to be active in the medtech sector. We support you in all important steps of a (re-)registration or adjustments of your QMS to new requirements and offer comprehensive consulting services.
Industrialisation
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Industrialisation (65 KB)
With our experience and knowledge we help you to create and validate your processes according to the regulations by ISO and GMP and to additionally reduce time and costs.
With our experience and knowledge we help you to create and validate your processes according to the regulations by ISO and GMP and to additionally reduce time and costs.
Clinical Evaluation
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Klinische Bewertung (119 KB)
Through our support you gain time and security for your clinical evaluation. The close collaboration with our specialists gives your staff additional competences regarding clinical evaluations.
Through our support you gain time and security for your clinical evaluation. The close collaboration with our specialists gives your staff additional competences regarding clinical evaluations.
Software Development
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Software Entwicklung (73 KB)
SW development for medtech according to the sets of standards of ISO 13485, ISO 62304 and FDA
SW development for medtech according to the sets of standards of ISO 13485, ISO 62304 and FDA
REGULA „Simplify your Regulatories“
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REGULA (82 KB)
Data-base driven application for efficient management and reporting of regulatory affairs activities.
Data-base driven application for efficient management and reporting of regulatory affairs activities.
Effective Copy Protection and Traceability of Disposables with RFID
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RFID (198 KB)
Disposables are regularly an important part of a business model. ISS AG developed an RFID driven concept which offers the highest possible copy protection and additional security features and at the same time high usability.
Disposables are regularly an important part of a business model. ISS AG developed an RFID driven concept which offers the highest possible copy protection and additional security features and at the same time high usability.
Q-Tool „simplify your tech file“
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Q-Tool (79 KB)
Q-Tool is an application that relieves your workload for the compilation of a techfile wherever possible including versioning, high traceability, full text search etc.
Q-Tool is an application that relieves your workload for the compilation of a techfile wherever possible including versioning, high traceability, full text search etc.
ISS Communication Framework
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DICOMM
A controlled and safe access also after the delivery of a medical device becomes increasingly important. Preparation of consumption figures and user profiles, distribution of updates, customer specific upgrades etc. For all those applications a secure data exchange between a main station and the individual devices is necessary. ISS AG offers a flexible and expandable solution validated for medtech.
A controlled and safe access also after the delivery of a medical device becomes increasingly important. Preparation of consumption figures and user profiles, distribution of updates, customer specific upgrades etc. For all those applications a secure data exchange between a main station and the individual devices is necessary. ISS AG offers a flexible and expandable solution validated for medtech.
Remote Deployment of Medical Device Software (REMEDI)
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REMEDI (78 KB)
Through the remote deployment solutions REMEDI by ISS AG the manufacturer of medical devices keeps control over the delivered devices. Specific and controlled updates with software validated for medtech use are easily executed without on-site support.
Through the remote deployment solutions REMEDI by ISS AG the manufacturer of medical devices keeps control over the delivered devices. Specific and controlled updates with software validated for medtech use are easily executed without on-site support.