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ISS AG carries the responsibility for the regulatory affairs of four companies. The tasks to assure the legal backup of the market presence include the systematic compilation of all products and markets, the supervision of the delays including alerting and regular reporting, responsibility of dossiers as well as registrations according to the requests of our customers.

• Overall responsibility traditional 510(K): ISS AG carried out the premarket notification (510(k)) for an ophthalmologic surgery laser (class II, laser class 4), an ophthalmologic diagnosis device as well as for a disposable injector system for intraocular lenses (class II).
• The overall responsibility for a 510(k)-dossier includes the evaluation of the risk class, the software level of concern, the laser class, the obtaining of suitable predicate devices, the composition of comparison charts, the design and execution of the in-vitro validation; the preparation, statistical analysis and presentation of all performance data; the preparation of a 510(k) summary, the compilation of the complete 510(k) dossier and the coordination of the activities with the US-agent.
• Overall responsibility special 510(k): In the case of a modified ophthalmologic device the clarifications done by ISS showed that a summary procedure is sufficient for the approval of this device in USA. ISS AG stated the reasoning for a special 510(k) towards the FDA, took over the preparation, statistical analysis and presentation of all performance data of the modified device, compiled the complete special 510(k)-dossier and carried out the submission.
• Support for traditional 510(k): For the approval of a dermatologic laser ISS AG prepares the clinical evaluation on the basis of a literature research and the available performance data.

• CE-marking of a disposable injector system for intraocular lenses: Within a scope extension ISS AG took over the overall responsibility for the dossiers as well as the cost and time management. In addition they supported the audit through the Notified Body and carried out the correction measures.
• CE-marking of an ophthalmologic diagnosis device: Within the scope extension ISS AG took over overall responsibility for the dossiers.

ISS compiled several submission dossiers in the format according to the summary technical documentation (STED) and the common submission dossier template (CSDT).

• Marketing approval of a disposable injector system for intraocular lenses: The mandate included the evaluation of the requested documentation according to the revised Pharmaceutical Affairs Law (PAL) in collaboration with the customer, the planning and support of the PAL-compliant biocompatibility studies, the preparation of the performance data, the compilation and completion of the existing documents of 510(k) and CE-marking as well as the coordination of the translations

• Marketing approval of an ophthalmic diagnosis device: The mandate included clarifications regarding the requirements of biocompatibility test and certificates, the obtaining and compilation of the required original documents, legalisations and certificates as well as the coordination of the activities with the local agents.

• Registration of an ophthalmological surgical laser
• Re-registration of an ophthalmological surgical device (still in progress)

We have accomplished registrations in the following other countries: Egypt, Algeria, Argentina, Australia, Brazil, Chile, China, Costa Rica, Ecuador, Guatemala, Hong Kong, India, Indonesia, Iran, Israel, Jordan, Canada, Columbia, Cuba, Kuwait, Lebanon, Malaysia, New Zealand, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam

Our previous mandates in this sector are confidential.

By combining our regulatory professional knowledge and our competences in the sector of software development an application tailored for the management of regulatory activities gradually developed. Since autumn 2007 we have also offered this software to our customers. Here you will find the fact sheet about REGULA™ and the article from the September edition 2009 of the Device Med.

For further information please contact Hansjörg Riedwyl.
Additional software applications developed by ISS AG can be found here.