Our consultants have hands-on experience with MDR, IVDR an global compliance frameworks, ensuring your documentation meets every standard.
Our consultants have hands-on experience with MDR, IVDR, and global compliance frameworks, ensuring your documentation meets every standard.
We adapt our approach to your product type, risk class, and market goals—no generic solutions, only what fits your business.
From technical documentation to post-market surveillance, we guide you through every stage of the regulatory journey.
With deep regulatory insight, we streamline submissions and minimize approval delays.
You stay informed at every step with clear deliverables, progress updates, and open communication.
We help you meet compliance requirements and gain approvals across global markets with expert regulatory guidance.
Ensure your medical devices meet all EU regulatory requirements under the MDR and IVDR gain CE marking approval for market access.
Navigate FDA regulations with confidence, from 510(k) submissions to quality system compliance for U.S. market entry.
Navigate FDA regulations with confidence, from 510(k) submissions to quality system compliance for U.S. market entry.
Resolve compliance gaps and align your quality systems with evolving regulatory standards.
Keep your regulatory and quality projects on track with structured planning, coordination, and execution.
Meet EU MDR and EU IVDR as well as UK MDR requirements with a trusted representative managing communication and post-market obligations.
From global registrations to remediation work and authorised representation, Simplimedica delivers full-spectrum regulatory support tailored to your goals. Get expert guidance every step of the way.
Simplimedica supports short-term, medium-term, and long-term project work for small and medium-sized businesses, as well as large corporations that may have a shortage in a skill or wish to outsource work to improve productivity.
We help companies establish quality management systems (QMS) compliant with medical device industry standards. We also provide guidance where regulatory requirements can be overwhelming and confusing. Simplimedica is a one-stop solution for ensuring that your company’s medical devices are firmly on track for being approved for sale in target markets.