Quality Assurance and Regulatory Consulting

MDS Denmark offers comprehensive Quality Assurance and Regulatory Consulting services to help your company navigate the complexities of medical device and software regulations. Our tailored approach provides cost-effective, flexible, and expert guidance throughout the product development lifecycle.

Elevate your Quality Assurance and Regulatory Affairs with our help

Technical Documentation Management

Compiling, reviewing, and updating technical files for medical devices, medical device software, and in vitro diagnostic devices to ensure full regulatory compliance.

Quality Management System Development

Building, auditing, and updating quality management systems for manufacturers, distributors, and importers, including standards such as ISO 9001, ISO 13485, ISO 14001, GLP, GDP, GMP, IEC 62304, and other harmonized standards.

Clinical Evaluation Report (CER) Support

Assisting in the compilation and synthesis of Clinical Evaluation Reports by integrating clinical trial data, product requirements, and equivalence comparisons to meet regulatory standards.

Outsourced Quality Management

Acting as an outsourced quality management partner, overseeing the implementation and maintenance of QA/RA systems.

Regulatory Documentation and Interpretation

Interpreting MDR and IVDR regulations to ensure that your documentation and processes align with regulatory requirements

Staff Training and Process Validation

Providing training on quality and regulatory topics to your team while validating production processes to maintain compliance and efficiency.

Project Management

Managing product design and development projects to ensure they meet both quality and regulatory standards while staying on schedule.

Why Choose MDS Denmark for Quality Assurance and Regulatory Consulting?

Expertise and Experience

Our team has extensive experience in quality management and regulatory consultancy, ensuring that you receive knowledgeable and reliable guidance.

Customized, Flexible Solutions

We tailor our consulting services to meet your unique business needs, ensuring that our solutions align with your company’s size, scope, and objectives.

Cost-Effective Support

Our comprehensive approach minimizes regulatory and quality management challenges while optimizing costs and resources.

Commitment to Excellence

We are dedicated to helping you achieve and maintain the highest standards of quality and regulatory compliance, ensuring safe, effective, and market-ready products.

Ensuring Excellence in Medical Device Quality and Regulatory Compliance

Partner with MDS Denmark to streamline your quality management and regulatory consultancy processes, reduce risk, and accelerate your time to market. Our expert consulting services empower you to focus on innovation while we handle the complexities of regulatory compliance.