Do you want to tidy up your process documentation? Has it grown over the years, with a lot of accumulated ballast? Your processes are not b4eing followed, are somewhat difficult to understand? Slim them down, based on COBIT, ITIL and Quqlity standards, individually for you and your needs!

Do you have to develop new requirements or revise and supplement existing ones? You have to define and develop requirements, systematically, structured, concise. 

Follow IREB (International Requirements Engineering Board) and quality management standards

Do you have an information security management system (ISMS) with or without certification according to DIN EN ISO/IEC 27001:2017? 

Do you want to set up an information security management system (ISMS)? 

Do you still need clarification? 

Do you need help to upgrade to 27001:2022, or to perform Internal audits, workshops, etc.?

I support you with analysis and optimization of your processes and your product documentation as part of your quality management system! 

• ISO 13485:2022, 
• EU Medical Device Regulation MDR – EU 2017/745

Do you want some risk management support for your information security management system? Risk analysis, assessment, residual risk, risk acceptance, rating scales, nominal, ordinal, cardinal, emotional... 

Threats, strategies of the bad

Own strategies and measures Coaching, training...?

Have you already updated the product risk file of your medical devices? 

Are you taking care about 

ISO 14971:2019 

EU MDR 2017/745 - Annexes 

IEC 60601-ff Usability, Labelling, IFU Software Life Cycle Cyber Security for Medical Devices Design FMEA, Process FMEA, SW-FMEA, FDA 21part820, MDSAP,  full Traceability?

Would you like risk management training for the people responsible for your ISMS? 

Integration of a risk management process into your company's ISMS support and strengthening of risk perception in your company. Understanding of assessments and analysis? 

Using asset based analysis, scenario based, and attack based analysis methods?

Are you looking for training for your employees to increase awareness of information security? Personal behavior, digital and physical dangers, sharpened attention?

Do you need support in defining guidelines / policies for your ISMS? according to DIN EN ISO/IEC 27001:2017 or to prepare for 2022?

Do you want to support your team with a digital solution for your management systems? Whatever standard is important to you, talk to us! ISO EN 9001, DIN EN ISO/IEC 27001, TISAX ISO EN 13485, MDR, 21part820 environmental management / EMAS occupational safety, supply chain law, data protection, AZAV, compliance ... 

Our Solutions will supports you in your assessment and evaluation of your management system.

The Solutions will support you tremendously with your audit preparation, gap analysis , process optimization, and documentation!