MDS Finland offers specialized training services in the field of medical device regulations, quality management, and other HealthTech topics. Our training programs are designed to enhance the professionalism of participants and provide them with a deep and comprehensive understanding of the HealthTech industry.
MDS Finland offers comprehensive biocompatibility testing services in accordance with ISO 10993, a critical standard for evaluating the biological safety of medical devices. Our expertise in ISO 10993 testing ensures that your medical devices are thoroughly assessed for potential biological risks, supporting their safety and efficacy.
MDS Finland offers specialized testing services to ensure compliance with the IEC 60601 series, a comprehensive set of standards crucial for the safety and performance of medical electrical equipment. Our focus on adhering to these standards demonstrates our commitment to the highest levels of safety and quality in medical device development.
MDS Finland provides comprehensive services as a European Authorized Representative, playing a crucial role for non-EU manufacturers who aim to place their medical devices on the European market. Our service ensures that your products comply with the regulatory requirements set by the European Union.
At MDS Finland, we understand the complexities and challenges faced by companies in the medical device and software industry. Our specialized services in quality assurance and regulatory compliance are designed to address these needs effectively and efficiently.
MDS Finland offers a comprehensive service to guide medical device manufacturers through the FDA approval process, ensuring access to the U.S. market. This process is essential given the increasing interest in the U.S. market and the lengthening backlogs for certification in the EU. Our services are tailored to the different types of FDA device approvals and clearances.
MDS Finland is committed to ensuring the highest standards in clinical evaluation reports (CER) for medical devices. In response to the more stringent requirements of the Medical Device Regulation (MDR) 2017/745, our approach to clinical evaluations has evolved to meet these new challenges.
At MDS Finland, we specialize in the preparation and management of technical files for medical devices, ensuring compliance with the EU Medical Device Regulation (MDR) 2017/745. Our services are tailored to meet the specific requirements of your medical device, whether it's software, sterile, or electronic.
At MDS Finland, our approach to internal auditing for Quality Management Systems (QMS) and Technical Files is designed to ensure the highest level of compliance and efficiency. We understand that internal auditing is a critical component in maintaining the integrity and effectiveness of QMS and Technical Files, especially under stringent regulatory frameworks like the EU MDR and IVDR.
At MDS Finland, we ensure that our team of specialists fulfills the vital role of the Person Responsible for Regulatory Compliance (PRRC), as mandated by the EU MDR and IVDR. Our PRRC specialists are not only a part of our core team but are also available for lease to complement your team’s regulatory compliance needs.
