Paladin Medical, Inc.
Paladin Medical® offers comprehensive regulatory, clinical, and technical services for medical device premarket applications and compliance. With extensive expertise and a hands-on approach, they assist companies in developing successful product submissions, risk analysis, and regulatory strategies. Their mission is to be a champion for product success by providing tailored services, training, and strategic planning to navigate complex regulatory landscapes globally.
Industries
Nr. of Employees
small (1-50)
Paladin Medical, Inc.
Stillwater, Minnesota, United States, North America
Services
Initial regulatory assessment, device classification, and submission pathway planning for US and international markets.
Draft and compile 510(k), PMA, De Novo, IDE and international submissions; prepare pre-submission packages and responses to deficiencies.
Provide QMS templates, SOPs, design control procedures, change control and Design History File support tailored to 21 CFR 820 and ISO 13485.
Design preclinical protocols, assess GLP status, provide clinical trial design, site qualification, monitoring and data management for IDE and submission support.
Plan and oversee verification/validation studies (software, hardware, sterilization, packaging, EMC, usability) and link testing to hazard analyses and claims.
Prepare international dossiers, coordinate with notified bodies and serve as U.S. Agent for foreign manufacturers including liaison for inspections, recalls and customs.
Initial regulatory assessment, device classification, and submission pathway planning for US and international markets.
Draft and compile 510(k), PMA, De Novo, IDE and international submissions; prepare pre-submission packages and responses to deficiencies.
Provide QMS templates, SOPs, design control procedures, change control and Design History File support tailored to 21 CFR 820 and ISO 13485.
Design preclinical protocols, assess GLP status, provide clinical trial design, site qualification, monitoring and data management for IDE and submission support.
Plan and oversee verification/validation studies (software, hardware, sterilization, packaging, EMC, usability) and link testing to hazard analyses and claims.
Prepare international dossiers, coordinate with notified bodies and serve as U.S. Agent for foreign manufacturers including liaison for inspections, recalls and customs.
Expertise Areas
- Regulatory compliance and submissions (US and international)
- Clinical trial design and management for medical devices
- Quality management systems (21 CFR 820 / ISO 13485)
- Biomaterials and biocompatibility assessment
Key Technologies
- ISO 10993 biocompatibility evaluation
- ISO 14971 risk management
- GLP compliance (21 CFR Part 58)
- Electronic data capture (EDC) systems
News & Updates
A detailed look at how forensic regulatory assessment can identify potential compliance gaps during mergers and acquisitions in the medical device industry.
Discussion on the importance of compliance with FDA's 21 CFR Part 820 regulation and its harmonization efforts with ISO 13485.
Information on FDA reclassification and exemption of certain medical devices, emphasizing the importance of understanding exemptions.
Guidance on meeting FDA cybersecurity requirements for medical devices with software or data export capabilities.
Advice on when to file a pre-submission (Pre-Sub) for a 510(k) application, including benefits and risks.
A detailed look at how forensic regulatory assessment can identify potential compliance gaps during mergers and acquisitions in the medical device industry.
Discussion on the importance of compliance with FDA's 21 CFR Part 820 regulation and its harmonization efforts with ISO 13485.
Information on FDA reclassification and exemption of certain medical devices, emphasizing the importance of understanding exemptions.
Guidance on meeting FDA cybersecurity requirements for medical devices with software or data export capabilities.
Advice on when to file a pre-submission (Pre-Sub) for a 510(k) application, including benefits and risks.