Bannick LLC, a primary device group

Bannick LLC operates as a specialized consulting firm serving the medical device industry with clinical, regulatory, quality, auditing, and medical writing services. The company focuses on helping device manufacturers navigate regulatory approvals in both US (FDA) and European Union (MDR/IVDR) markets.

The firm's service portfolio spans the complete regulatory lifecycle, including clinical study design and protocol development, regulatory strategy and submission preparation, MDD to MDR transitions, clinical evaluation reports, post-market clinical follow-up plans and reports, quality management system development, and various audit services. Their team includes biostatisticians, regulatory affairs specialists, clinical affairs experts, and medical writers with expertise in ISO standards including 14971, 14155, 13485, and IEC 62366.

Bannick emphasizes a subject matter expert approach, with leadership noting their commitment to hiring experienced professionals rather than rapid growth with junior staff trained at client expense. The company provides training on MDR regulations, clinical evaluation processes, and various ISO standards.

Choose Bannick when you need regulatory and clinical expertise from experienced professionals who understand the intersection of FDA requirements, EU MDR/IVDR compliance, and clinical evidence generation. The firm's emphasis on hiring subject matter experts rather than junior staff trained on client projects may appeal to companies seeking consultants who can immediately contribute strategic value.

Expect a consultative engagement model focused on regulatory strategy, clinical documentation, and audit readiness. The firm's understanding of both regulatory requirements and future audit considerations in their deliverables suggests a thorough, compliance-focused approach rather than simply processing submissions.

Bannick operates exclusively in the medical device sector, providing regulatory and clinical services specifically tailored to device manufacturers' needs. Their healthcare specialization encompasses FDA 510(k) and PMA pathways, EU MDR and IVDR compliance, clinical trial design under ISO 14155, and post-market surveillance requirements. The firm's expertise in medical device quality management systems (ISO 13485), risk management (ISO 14971), and usability engineering (IEC 62366) demonstrates deep vertical focus.

The company's work on clinical evaluation reports, PMCF plans and reports, and MDR technical documentation reflects specific understanding of European medical device regulations. Their BIMO audit readiness services address FDA's Bioresearch Monitoring program requirements for clinical investigators and sponsors.

Medical device manufacturers of all sizes preparing for FDA submissions or EU market access under MDR/IVDR regulations. Companies particularly benefit if they're navigating complex clinical evidence requirements, transitioning legacy products from MDD to MDR, preparing for FDA BIMO audits, or need clinical evaluation reports and PMCF plans that will withstand notified body and regulatory scrutiny. Organizations seeking strategic regulatory counsel rather than just documentation services.