MakroCare specializes in providing comprehensive regulatory and quality assurance services for medical devices and biopharmaceuticals. Their offerings include regulatory strategy, quality management system (QMS) management, and clinical trial management, which encompasses clinical monitoring, biostatistics, and medical writing. The company emphasizes the importance of compliance with stringent regulatory standards, such as those set by the FDA and ISO, to ensure the safety and efficacy of medical devices. Additionally, MakroCare supports clients in navigating the complexities of labeling, including Unique Device Identification (UDI) consulting and electronic instructions for use (eIFU), which are critical for market access and regulatory approval.

In the realm of risk management, MakroCare assists manufacturers in adhering to international standards like ISO 14971, which is essential for evaluating and mitigating risks associated with medical devices. Their services include conducting gap analyses, developing risk management plans, and performing benefit-risk evaluations to align with evolving regulatory requirements. By leveraging their expertise, MakroCare aims to streamline the compliance process for manufacturers, thereby facilitating timely market entry and enhancing patient safety through rigorous monitoring and assessment of medical devices throughout their lifecycle.

United States

MakroCare is expert Regulatory Consulting and Clinical Services partner for pharmaceutical, biotechnology and medical device industries. Our global/regional teams and fit-for-purpose costing models to your development strategy, regulatory management, clinical research, medical/scientific support and quality assurance areas. MakroCare has operations and presence in US, UK, EU, and Asia.

MakroCare

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