MedLaunch

Medical Device ConsultantsWe help medical device developers navigate the complex web of domestic and international regulations so they don't face costly delays or rejections.

Regulatory SubmissionsPreparing and managing critical submissions, such as FDA 510(k) premarket notifications, De Novo pathways, or PMAs.

Global Market AccessStructuring strategies for international compliance, including CE Marking under the European MDR/IVDR requirements.

Device ClassificationIdentifying the precise regulatory pathways and standards based on the device’s risk profile and intended use.

Quality Management Systems (QMS)We build, implement, and maintain robust quality systems that ensure a manufacturer's operations comply with strict industry regulatoions and standards. (FDA QMSR, ISO 13485, TGA, EU MDR, UK MDR)

Remediation & AuditingHelping companies handle or resolve regulatory roadblocks, such as answering FDA Form 483 warning letters or correcting audit non-conformances.

Risk Management & Life-Cycle SupportWe ensure compliance is maintained throughout the entire life cycle of the medical device, from early design down to post-market surveillance. (ISO 14971, risk assessmetns, FMEAs, hazard analyses, usability and human factors engineering)

Design Controls & DocumentationHelping engineers organize their Design History Files (DHF) and Device Master Records (DMR) so the technical data is seamlessly aligned with regulatory expectations.

Software Compliance (IEC 62304) and CybersecurityAssisting innovators with specialized frameworks required for Software as a Medical Device (SaMD) and connected health technologies.