MedDev Rešitve, Marcia Elena Podboršek s.p. MDR and IVDR consulting in the EU

MDR and IVDR consulting in the EU helps in developing medical products and putting them on the market.

Are you a company that is active in the field of medical devices and are facing the challenges of how to produce a product and present it to the market to meet the obligations of the requirements of the MDR and IVDR regulations?

Trust us to provide some guidance with MDR and IVDR consulting in the EU.

The correct address, for help and advice, is the company MedDev Rešitve, Marcia Elena Podboršek s.p. from Central Slovenia.

MDR and IVDR consulting in the EU

With a suitable education (master's degree in pharmacy) and as much as 20 years of experience in healthcare and pharmacy, with an emphasis on medical devices, I offer you professional regulatory advice to fulfill the obligations of the requirements of the MDR and IVDR regulations of the European Commission.

I offer MDR and IVDR consulting in the EU in the field of regulation of medical devices. I advise companies in the field of medical devices and adapt my services to individual projects and client needs.

In addition to extensive knowledge and experience, I have completed ISO 13485 auditor training.

MDR and IVDR consulting in the EU in the field of regulation of medical devices is a specialized form of consulting, where I focus on providing up-to-date information in accordance with legislation, guidance and providing expertise to companies engaged in:

• production,
• distribution
• or marketing of medical devices.

Medical devices include many different products, such as diagnostic devices, surgical instruments, treatment and rehabilitation devices, and other equipment used for medical purposes.

We provide professional MDR and IVDR consulting in the EU

Medical device regulation is a broad system of regulations, standards and procedures that companies must follow to ensure the safety, efficacy and legal compliance of their products.

Our consulting in the field of regulation of medical devices includes:

• advice on activity registration,
• consulting in the preparation of after-sales monitoring of a medical device on the market,
• advice on the registration of a medical device,
• MDR/IVDR consulting and compliance guidance,
• inspection during the preparation of documentation, giving recommendations for improvements,
• consulting in the implementation of the assessment,
• advice on setting up a vigilance system,
• depending on the wishes of the client, I carry out individual internal training.

MDR and IVDR consulting in the EU is key to ensuring compliance with legislation, reducing risks and successfully marketing products in this demanding field.

For more information about my services, field of work and cooperation, I am available to you via the given contact information.