GSI-CERT I Certification Made Simple
Get Your Product Certified
We Are Your Trustworthy Partner located in München/ Germany.
- Our Services -
Preparing for Your Success: We Provide Trustworthy Services
Achieve CE certification with professional support and hands-on spirit.
Quality Training
We offer training and workshops on quality-related topics. Our certified trainers are long-time experts in their field and are always looking forward to working with you.
Quality Consulting
Our consulting experts combine high methodological expertise in quality, testing and regulatory affairs. From specific consulting services to coaching for your individual challenges to implementation.
Product Certification
We are your competent partner when it comes to audits and certification. As an independent certification body, our goal is to offer certification, especially for small and medium-sized companies, in an attractive, high-quality manner and at economically reasonable cost.
Technical Testing
We offer tailor-made technical testing protocols for your products according to the latest product standards. Together with partner laboratories we offer testing for hardware and software products.
Cybersecurity Services
Our experienced and qualified cyber security experts help you achieve ISO 27001 certification fast and effectively.We offer penetration tests, security assessment and further services to comply with all relevant security standards.
Data Protection/ GDPR
We are your partner to achieve data protection compliance according to the GDPR. We provide an external data protection officer and a data privacy documentation to comply with European data protection regulation.
- About Us -
Bring Your Product To EU Market
We are experts in the field of market access and regulatory affairs, dedicated to help company`s solve their complex regulatory challenges.
Our team of experienced quality and regulatory affairs managers provide a full range of services, from developing market access strategies to product certification.
We believe in pragmatic and lean solutions to make our clients happy. We don´t sell consulting services as others do, we support with customized solutions to comply with the European regulations.
Quality is on our DNA and we provide high-class services at affordable prices.
We help our clients to fulfil regulatory requirements to enter the European market.Our service is based on several years of hands-on experience bringing software and hardware products to the European market.
- Our Case studies -
Proud Cases That Make Us Stand Out
Learn more about our recent case studies.
Technical PRodUCT Certification
IoT Hardware Device →
InforMation Security Quality Management Systen
Information Security compliance
Want to Work with Us?
Don't hesitate to contact us on moc.liame%40tcatnoc and learn how we can help your business.
GO-TO-MARKET STRATEGY
Software as a Medical Device
- Contact us -
Get Your Product Market Ready
Compliance Made Simple - with our support.
- News and articles -
Interesting Article Cybersecurity
Dive into the world of cybersecurity.
EU AI Act| Sept 01, 2024
The EU AI Act and its impact on the medical device industry
The Medical Device Regulation (MDR) sets stringent requirements for medical devices, emphasizing safety, performance, and risk management. The EU AI Act is reshaping the landscape for AI-based medical devices in Europe by providing a unified framework for AI systems, from development through marketing and use, based on a proportionate risk-based approach. Under the definition of an artificial intelligence system, many software products classified as medical devices, even those already on the market, will be considered AI systems for the purposes of the AI Act and will therefore need to comply with its requirements. The EU AI Act will introduce additional obligations, particularly around transparency, accountability, and data governance. This will add complexity to the regulatory process for bringing medical devices to the European market, making it essential for manufacturers to integrate both MDR and AI Act requirements into their quality management systems.