GSI-CERT GmbH I EU Product Certification Made Simple
Get Your Product Certified
We Are Your Trustworthy Partner located in München/ Germany.
- Our Services -
How Can Manufacturers Bring Products to the EU Market?
GSI-CERT supports EU and non-EU manufacturers bringing products to the EU market with a clear regulatory strategy and CE marking preparation.
We support technical documentation, testing coordination and the implementation of ISO management systems, including preparation for independent certification where applicable.
More Precise
Clearer Regulatory Decisions: We define the applicable requirements, conformity route and documentation scope early to reduce uncertainty and rework.
More Cost-Efficient
Lower Compliance Costs:Practical implementation, lean coordination and focused project planning help avoid unnecessary testing, delays and duplicate work.
Faster Execution
Faster Market Access:Short decision paths, responsive communication and efficient project coordination help move products to the EU market faster.
- Our Services -
Which EU Compliance Services Do Manufacturers Need?
Achieve CE certification with professional support much faster.
Choose the compliance support you need, from EU market access and MDR/IVDR to testing, cybersecurity and ISO management systems, with direct expert guidance from assessment to implementation.
CE Marking & EU Market
GSI-CERT supports manufacturers with identifying applicable EU requirements, defining the conformity-assessment route, preparing technical documentation and coordinating required testing for CE marking and EU market access.
MDR & IVDR Registration
Regulatory support for medical device and IVD manufacturers, including EU market-access strategy, technical documentation, registration and preparation for applicable conformity-assessment activities according to MDR and IVDR regulations.
Product Certification
GSI-CERT helps manufacturers identify applicable certification requirements, prepare technical documentation and coordinate testing and third-party certification where required.
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.
ISO Management Systems
Support for implementing and improving quality management systems, including gap assessment, documentation, internal audits and preparing for certifications or conducting independent certifications.
How do non-EU Manufacturers of Medical Device enter the EU Market?
For manufacturers outside the EU, market access requires more than CE marking.
GSI-CERT provides a clear regulatory path from MDR/IVDR requirements and technical documentation to EU Authorized Representative coordination, registration and conformity-assessment preparation.
One experienced contact coordinates the key workstreams and helps reduce rework, delays and unnecessary compliance effort.
- 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 and learn how we can help your business.
GO-TO-MARKET STRATEGY
Software as a Medical Device
- Contact us -
Get Your Medical Device Market Ready
Compliance Made Simple - with our support.
- News and articles -
Interesting Article Cybersecurity
Dive into the world of cybersecurity.
EU AI Act
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.
Our Values
We always work hard to improve our goods and services to achieve higher results for our clients. We love challenging tasks that require an innovative approach. Thus, if your business needs a unique solution, we are ready to fine-tune our existing products to meet all your demands.
Our company is a group of devotees sharing mutual priorities and values. We know that only those committed to their work can provide the best-quality products and services. That’s why every person that wants to join our team should undergo rigorous selection.