Regulatory affairs

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Regulatory Affairs

The approval of medical devices is a complex subject that covers a multitude of areas and poses a challenge for those placing medical devices on the market. Attention must be paid not only to pan-European laws and regulations, but also to specific legislation of the individual Member States. Various applicable standards must be identified and fulfilled, in regards to the product documentation in itself, but also in regards to quality management in the company. Subsequently, it is vital to monitor the continuous changes in the legislation, and to keep the existing documentation up to date and compliant.

The employees of MDSS Consulting GmbH offer extensive experience in interpreting and implementing regulatory requirements worldwide. With our consulting services, we safely navigate your company through the jungle of laws, standards, guidelines, and regulations.

Qualitätsmanagement

Our consulting services at a glance

Regulation (EU) 2017/745 (MDR) & Regulation (EU) 2017/746 (IVDR)

Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) establish the safety and performance requirements for medical devices and in vitro diagnostic medical devices in the EU. They strengthen health protection, increase transparency, and improve traceability. Stricter requirements and new obligations create uniform standards for innovation and patient safety.

Quality management

Quality management encompasses measures to ensure and improve the quality of products, services, and processes. It promotes efficiency, customer satisfaction, and competitiveness through clear structures and continuous optimization.

Internal and external audits as well as supplier audits

Internal audits examine internal company processes for standards and potential for optimization. External audits assess compliance with external specifications and certification requirements through third parties. Supplier audits ensure the quality and reliability of suppliers and strengthen the supply chain.

UDI marking

The UDI (Unique Device Identification) marking ensures the unambiguous identification and traceability of medical devices. It increases patient safety and fulfills regulatory requirements of the MDR and IVDR.

Risk management

Risk management involves identifying, assessing, and managing risks to minimize damage and safely achieve goals. It is a continuous process that develops and monitors preventive measures to reduce risks.

GMDN code search

The GMDN (Global Medical Device Nomenclature) code search is used to identify and classify medical devices. Manufacturers use these codes to clearly describe their products and comply with regulatory requirements such as the MDR and IVDR. The codes enable standardized communication and facilitate registration and market surveillance.

CE marking

The CE marking indicates that a product meets EU safety, health, and environmental requirements. It is mandatory for medical devices and enables free trade within the European Economic Area.

Technical documentation

The technical documentation contains all documents that demonstrate a product’s safety, performance, and compliance with regulatory requirements, such as the MDR or IVDR. It includes, among other things, product descriptions, risk assessments, and test reports and is mandatory for market authorization.

Educational programs

Educational programs provide targeted knowledge and skills to prepare employees for specific requirements or expand their competencies. They are crucial for quality assurance, regulatory compliance, and continuous development within the company.

Conformity assessment

The CE marking indicates that a product meets EU safety, health, and environmental requirements. It is mandatory for medical devices and enables free trade within the European Economic Area.

Person responsible for regulatory compliance

The Regulatory Compliance Officer (MDR and IVDR) ensures that a company meets legal requirements. They oversee technical documentation, declarations of conformity, market surveillance, and serious incident reporting, and act as the central interface with authorities.

Standards research

Standards research involves the systematic search for relevant standards and technical norms applicable to products, processes, or services. It serves to meet legal requirements, such as the MDR and IVDR, and to ensure quality and market approval.

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The free initial consultation includes either a 30-minute telephone call, an online meeting or an on-site meeting at MDSS Consulting GmbH after prior coordination.
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