Obelis Academy

Regulatory frameworks in the European Union are constantly evolving. At Obelis, we believe that knowledge on the regulatory and quality requirements plays a crucial role to facilitate the product-to-market process and to secure your business in the EU.

Obelis Academy offers a range of dedicated training sessions conducted by industry experts designed to make your organization familiar with the EU legislation surrounding medical devices, in-vitro diagnostics, cosmetic products, other CE-marked devices and more.

The content of the training courses can be customized according to your needs. This makes our trainings suitable for those new to the EU market as well as regulatory and/or quality professionals seeking to deepen their regulatory expertise.

Obelis training courses can be attended online or performed on-site:

• Online trainings (2 hours) are ideal for those looking for a concise overview of the most important industry-related requirements.
• On-site trainings (1 or 2-day program) are the best tool to share in-depth technical and practical knowledge surrounding the applicable legislation(s) for your devices. During the training, the on-site expert will assist you to determine the best compliance strategy for your business.

Industry Specific Training Programs

Medical Devices & In-Vitro Diagnostics

Medical devices and IVD devices constitute of a considerable part of the EU healthcare sector. From now until 2025, two new regulations will replace the current medical device & IVD regimes.

Obelis EU MDR & IVDR Training Program is designed to prepare manufacturers for the new compliance procedures and covers among others the below topics:

·        MDR & IVDR Transition Highlights & Strategies;

·        New Essential Requirements & Conformity Assessment Routes;

·        Technical File Requirements – Gap Analysis from Directive to Regulation;

·        EUDAMED, UDI, PRRC;

·        New Requirements for Economic Operators;

Cosmetic Products

The European market offers a significant potential for cosmetic product manufacturers, producers and original brand labellers (OBL). Many have secured their market access by complying with the EU Cosmetic Legislation.

Would you like to enter the European cosmetic product market? Follow Obelis cosmetic training and learn more about the compliance process by letting us answer your questions on:

• PIF Compilation;
• Cosmetic Product Laboratory Testing;
• Safety Assessment Procedure;
• Artwork Design according to EU requirements;
• CPNP Notification;

CE Marking Training

Does your company manufacture toys, protective gloves or pressure equipment? Is your company specialized in developing devices incorporating radio equipment technologies? Or does your business revolve around construction products?

At Obelis Academy, you can attend CE-marking courses on the following legislation:

• Toys Safety Directive;
• Radio Equipment Directive;
• Electromagnetic Compatibility Directive:
• Machinery Directive;
• Personal Protective Equipment Directive;
• Pressure Equipment Directive;
• Construction Product Regulation;
• And more

Invest in your company’s future by mastering the knowledge on the EU regulatory & quality requirements of your industry.

Get a fully customized course offering & schedule your training today by filling in the below request form.