From selective consulting to outsourcing
With our experience in Europe, North and South America, Asia and the Middle East we can help you to a rapid market approval in all regions. Whether for short or long term contracts – we can manage your product registrations for all target markets, supported by our in-house software REGULA™. We offer long-term experience in writing clinical evaluation reports.
RA-Management – Per Request or Long-Term Contracts
Whether for short or long term contracts – we can manage your product registrations for all target markets, supported from our in-house software REGULA. We will drive the complete regulatory process. This includes monitoring your deadlines and expiration dates as well as overseeing the document transfer with the authorities or your on-site partners until the approval is obtained. Our vast practical experiences including some exotic markets is helpful for dealing with and navigating country specific requirements.
Based on our experiences, additional research and our worldwide network of experts we respond on your specific questions concerning Regulatory Affairs matters. We even have one native Chinese staff member designated for the China and Taiwan market space.
Submission Dossiers for your Product Registrations
510(k), STED or CSDT format – based on your technical documentation we will compile submission dossiers in the format the target markets and Regulatory Affairs demand.
Assessment and Benchmarking of your Regulatory Strategy
Many companies assess the importance of Regulatory Affairs only with regard to Time to Market and Compliance. Regualtory Affairs are often recognized as strategic business criteria and relevant for product entry into the market only in retrospect. With a neutral assessment and a Benchmarking by our team, you will receive position-fixing and specific suggestions for a better integration strategy with respect to the relevant Regulatory Affairs issues in your projects and processes.
Combination Products and IVD
Our previous mandates in this sector are confidential.
ISS maintains a very well developed worldwide knowledge management. This makes it possible to create RA Intelligence tailored to your company and to make your RA processes and ultimately your company more efficient and cost-effective. The various elements ensure that you have a better grip on RA issues and that your staff is adequately trained.
- Reduced load owing to tailoring to your products and markets
- Systematic training of your employees
- Ongoing preparation for the new EU regulation MDR
- Up-to-date information on international markets outside the EU and USA
- List of Applicable Standards always up-to-date
- Keep an eye on the Vigilance
- No costs for expensive databases
- Calcualable costs
Based on observations on our daily practices ISS AG developed sectoral trainings which are provided to customers directly or as part of courses at the Universities of Applied Sciences in Berne. Important topics include regulatory requirements about medical devices and the use of statistical tools within the MedTech (Medical Technology) industry.
Fundamentals of Regulatory Affairs and Patents
This lecture of the University of Berne presented as part of the Master Course Biomedical Engineering conveys the practice-oriented knowledge about regulatory requirements and the patent systems for medical devices. The product life cycle is treated regarding to legal framework conditions, approval procedures, standardization and patent law. Guest lecturers illustrate additional topics out of that often ignored but inevitable field of the medical technology industry.
Selected Topics to Regulatory Affairs
Within the Medical Technology Center at the University of Applied Sciences of Berne, ISS AG presents several subject specific lectures on Regulatory Affairs within the medical technology and medical information technology study programs. Various topics related to the clinical evaluation, market surveillance and documentation are presented in detail.
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.
More information about REGULA™ can be found here.