The EU Regulatory landscape can be difficult to navigate. In addition to a complex system, laws are updated frequently, and new regulations are replacing existing directives. Staying up to date and be prepared for changes is crucial for manufacturers to be compliant and avoid breaches.
For both EU and extra-EU manufacturers, we offer consultancy and training services to help you understand and apply the appropriate EU legislation.
The Representative of choice
Our consultancy services include:
- Regulatory support and advice
- Ensure compliant technical documentation
- Evaluate claims and labels
- Compilation of documents
- Regulatory research
- Updates on regulatory matters
- Translations
This means your EU consultant will support you to:
- Successfully penetrate the EU marketplace
- Ensure compliant technical documentation
- Conduct EU Research and Clinical Investigations
- Evaluate EU Market Claims
- EU Labeling & Translations
- Remain up-to-date on legislative/economic/political matters that may influence your product compliance (i.e. Brexit)
- Provide support in determining an effective overall EU Market Strategy (i.e. distribution, warehousing, etc)
To strengthen your knowledge on the EU Regulatory system, we offer trainings on a wide range of topics. We can guide you through various Regulatory matters with online or on-site trainings. Some of our strongest areas of expertise are medical devices and IVD medical devices, cosmetics, food supplements, aesthetic devices, electronics, protective equipment, and other.
From general insights to the most challenging aspects, a few of our consultancy areas on which we also propose trainings are:
- European Authorized Representative, EU Responsible Person
- Technical File Creation, Review
- Product Registration, National Device Registration
- Vigilance, Clinical Evidence, Clinical Evaluation Report, Risk Management
- Product Classification
- Free Sales Certificates (FSC)
- Harmonised Standards
- Trademark Submissions
- Navigating Obelis’ information platforms (MDlaw and COSlaw)
In addition to trainings, we offer various webinars held by our experts. On both Obelis website and Obelis’ information platforms, MDlaw and COSlaw, you can find a vast selection of webinars.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
