Your certification partner since 2009.

The organization "MedStandart" offers certification services to help your business enter the European market. Trust our expertise and obtain certificates that confirm the safety and quality of your products.
Certificate Registry

European Certification

European certification, and consequently CE marking, is the key to successful trade in Europe. With the certificate, you confirm that your product complies with EN standards and is safe.

International ISO Certification

Certificate of Global Quality Standards. Main Types of ISO Certifications:
ISO 9001 - Quality Management Systems
ISO 13485 - Medical Devices
ISO 22000 - Food Safety Management Systems
ISO 14000 - Environmental Management

EUDAMED Registry

Registration of a medical device in the EU Ministry of Health Registry - EUDAMED. To be included in the European Medical Devices Registry, a technical dossier must be prepared in compliance with European legislation.

Representative in the EU

For companies without an office or branch in the European Union, having an official representative is required. We offer an authorized representative service registered in Poland, which includes not only legal representation but also active participation and interaction with regulatory authorities in the EU.

Training

MedStandart provides training programs in the field of technical regulation within the European Union.
Consulting and Training:
  • ISO 9001, ISO 19011
  • ISO 13485
  • Legislation on trade within the EU
Our courses are designed for professionals who want to gain expert knowledge in these important areas.

Business Establishment in the EU

We will help you select the type of activity in accordance with EU standards and determine the optimal taxation. We provide assistance with registration and ensure ongoing accounting and legal support for your business.

6 Steps to Bring Your Product to the EU Market

  • 1. Identification of European directives and regulations applicable to your product.
  • 2. Determination of legal requirements applicable to the product.
  • 3. Identification of European standards and quality indicators.
  • 4. Conducting the product conformity assessment procedure.
  • 5. Preparation of technical documentation and product labeling.
  • 6. Issuance of the Declaration of Conformity.

At the same time, additional requirements from your business partners should be considered. For example, demonstrating production stability can be achieved by implementing and certifying a management system in compliance with international ISO standards.

ECS "MEDSTANDART"

The European Certification Center "MEDSTANDART" provides certification and declaration services across European countries.

The team of professional auditors at MEDSTANDART (Europe) has joined the global IAF CertSearch database, which stores information about certificates issued by accredited certification bodies for management systems worldwide. This database serves as a reliable source for verifying the validity of these certificates.

With IAF CertSearch, certified clients can demonstrate their certified management system to consumers and partners worldwide.

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MedStandart is an official member of the Global Medical Device Nomenclature (GMDN). This international association represents the pinnacle of standardization, classification, and categorization of medical devices.

GMDN coding is a necessary step for any manufacturer aiming to register their product in EUDAMED—the global leader in medical device registration and management. This ensures recognition, trust, and global acceptance of your product within the international medical community.

We have extensive experience in international certification and technical regulation!
We know how to grow your business!

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