Medical device regulatory support

Consonance offers specialised medical device regulatory support to help navigate the complex global regulatory landscape and bring compliant products to market efficiently. Our regulatory team combines deep knowledge of Medical Device Regulation (MDR), ISO 13485 quality systems, and certification requirements with practical experience guiding projects from early planning through successful submission. We provide strategic regulatory consulting that includes implementation support for ISO 13485 quality management systems and preparation for CE marking under EU MDR. Our services cover technical documentation auditing, development of certification strategies, and targeted guidance on meeting regulatory expectations for both hardware and software medical devices (including SaMD). Our experts work closely with your internal teams to map regulatory pathways, prepare and review submissions, and coordinate interactions with notified bodies and legal counsel. This end-to-end approach ensures alignment with applicable standards, reduces review risks, and supports timely progress from submission to approval. Consonance’s regulatory support is designed to integrate seamlessly with engineering and manufacturing activities, embedding compliance considerations early in the product lifecycle. Whether you are implementing ISO 13485, pursuing CE marking, or optimising certification documentation, our regulatory specialists help ensure your medical device meets stringent safety, performance, and market access requirements.