Compliance is more than a legal requirement. It demonstrates your commitment to quality and reliability to your customers.

We provide services for writing and reviewing technical documentation in full compliance with the Medical Device Regulation (MDR 2017/ 745). 

Our team works closely with you to ensure that every aspect of your documentation, from risk assessments to post market surveillance, meets the stringent MDR requirements. We streamline the process to help reduce compliance risks and ensure your medical devices are ready for market approval. With our in-depth knowledge of MDR standards, we’re here to make your submissions smoother and more efficient.

We provide expert support for IEC 62304 compliance, ensuring your medical device software development processes meet international standards. 

Our team works with you to establish and maintain a robust software lifecycle management system, including risk management, documentation, and verification processes required by IEC 62304. We help you align your software development practices with regulatory requirements, reducing risks and ensuring compliance. With our in-depth knowledge of IEC 62304, we guide you through every stage of certification, enabling smoother audits and regulatory approvals. 

We offer expert support for compliance with IEC 60601-1 standards, focusing on the latest revisions for medical electrical equipment. 

Our team assists you in understanding and implementing the updated requirements of this critical standard, ensuring your medical devices meet safety and performance criteria. We guide you through risk management, testing protocols, and documentation to ensure full compliance with the latest IEC 60601 standards. With our in-depth knowledge of the revisions, we help you navigate the complexities of the standard, streamline the certification process, and enhance the safety and reliability of your medical devices. 

We specialize in providing expert support for Medical Device ISO 13485 compliance and certification. 

Our team works closely with you to develop and refine your quality management system, ensuring it meets the stringent requirements of ISO 13485 for medical devices. We assist with documentation, process optimization, and audits, preparing you for successful certification. With our deep understanding of ISO 13485, we help streamline your quality management system, reduce risks, and enhance the efficiency of your operations. 

We offer comprehensive support for Medical Device Single Audit Program (MDSAP) compliance and audits. 

Our team guides you through the preparation process, ensuring that your quality management systems meet the MDSAP requirements. We assist in developing and refining your documentation, conducting internal audits, and preparing you for external MDSAP audits. With our expertise, we help you navigate the complexities of MDSAP, reducing the risk of non-compliance and ensuring smoother audit outcomes. 

We offer expert support for ISO 27001 compliance and certification, ensuring your organization’s information security management system (ISMS) meets the highest standards. 

Our team assists you in developing and implementing effective security controls, conducting risk assessments, and preparing the necessary documentation for certification. We help you safeguard sensitive data, mitigate risks, and ensure compliance with ISO 27001 requirements. With our guidance, you can strengthen your cybersecurity posture and achieve smoother certification. 

We offer specialised support for ISO 42001 preparation, compliance and certification to ensure you are compliance to the European Artificial Intelligence act. 

Our team helps you develop and implement a comprehensive Artificial Intelligence Management System (AIMS) that meets the requirements of ISO 42001. We assist with risk assessments, process optimization, and documentation to enhance your organization's ability to anticipate, respond to, and recover from disruptive events. With our expertise, we guide you through the complexities of ISO 42001, ensuring that your resilience management practices are robust and effective. 

We provide expert guidance for ISO 9001 compliance and certification. 

Our team helps you develop, implement, and optimize your quality management system to meet the rigorous requirements of ISO 9001. We support you with process improvements, documentation, and internal audits, ensuring your organization is fully prepared for certification. With our extensive experience in ISO 9001 standards, we help streamline your path to compliance, improving efficiency and reducing the risk of non-conformities. Rely on us to support you through every stage of achieving and maintaining ISO 9001 certification.

We provide tailored Interim Regulatory Affairs (RA) support to meet your organization’s needs. 

Our experienced professionals step in to manage your QA and RA functions during transitions, expansions, or resource gaps. We handle regulatory submissions, ensure compliance with industry standards, and oversee quality management systems processes to maintain smooth operations. With our interim support, you benefit from expert guidance and continuity, ensuring that your quality and regulatory activities remain effective and aligned with current requirements.