Bannick
Regulatory and clinical consulting firm focused on medical device product development and market entry. Offers clinical study design and management, regulatory strategy and submissions, quality management and auditing, medical writing, and biostatistics support for US, EU and global regulatory pathways.
Industries
Nr. of Employees
small (1-50)
Bannick
Marathon, Wisconsin, United States, North America
Services
End-to-end clinical services including study strategy, protocol and CRF development, clinical monitoring, investigator meetings, site training, and statistical analysis.
Regulatory strategy development, submission preparation for US/EU/global markets, MDD to MDR gap assessments, and FDA meeting support.
Preparation of CERs/CEPs, PMCF plans/reports, SSCPs, clinical study reports, manuscripts, literature reviews and validation reports for regulatory and scientific audiences.
QMS development, documentation, internal and supplier audits, technical file audits, gap assessments, and CAPA/audit response support aligned with ISO 13485 and regulatory requirements.
Study design consultation, database setup, statistical analysis and report preparation to support clinical studies and regulatory submissions.
End-to-end clinical services including study strategy, protocol and CRF development, clinical monitoring, investigator meetings, site training, and statistical analysis.
Regulatory strategy development, submission preparation for US/EU/global markets, MDD to MDR gap assessments, and FDA meeting support.
Preparation of CERs/CEPs, PMCF plans/reports, SSCPs, clinical study reports, manuscripts, literature reviews and validation reports for regulatory and scientific audiences.
QMS development, documentation, internal and supplier audits, technical file audits, gap assessments, and CAPA/audit response support aligned with ISO 13485 and regulatory requirements.
Study design consultation, database setup, statistical analysis and report preparation to support clinical studies and regulatory submissions.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions (US, EU, global)
- Quality management system implementation and compliance
- Medical writing and clinical evaluation
Key Technologies
- Clinical study protocol and CRF development
- Statistical analysis and biostatistics
- Quality management systems (ISO 13485, 21 CFR 820, ISO 9001)
- Regulatory submission preparation (510(k), PMA, De Novo, IDE, CE/MDR)
News & Updates
Silver sponsorship and workshop on writing clinical evaluation reports according to MDR; company speakers presented at the AMWA Medical Writing and Communication Conference.
Company participation at MedTech MVP Conference 2022 discussing neuromodulation and medtech clinical trials.
Article addressing FDA BIMO audit preparedness for clinical managers and study documentation practices.
Article discussing IVDR implementation challenges and performance evaluation reports for IVD devices.
Article comparing registry-based PMCF activities and investigator-initiated trials for post-market evidence generation.
Company founder and CEO was selected among the Top 25 Women Leaders in Medical Devices of 2022 by The Healthcare Technology Report.
Silver sponsorship and workshop on writing clinical evaluation reports according to MDR; company speakers presented at the AMWA Medical Writing and Communication Conference.
Company participation at MedTech MVP Conference 2022 discussing neuromodulation and medtech clinical trials.
Article addressing FDA BIMO audit preparedness for clinical managers and study documentation practices.
Article discussing IVDR implementation challenges and performance evaluation reports for IVD devices.
Article comparing registry-based PMCF activities and investigator-initiated trials for post-market evidence generation.
Company founder and CEO was selected among the Top 25 Women Leaders in Medical Devices of 2022 by The Healthcare Technology Report.