Being in the Medical Device Business we fully understand the challenges posed by FDA and other regulatory authorities. Most companies find it extremely difficult to find their way through the web of regulatory hurdles. The challenges are not only limited to the complex regulatory laws and stipulations but also involves the huge cost of hiring Consultants.
Biomedical Devices of Kansas is committed to provide other Medical Device Companies with the best regulatory and compliance services at a highly competitive price. Our Competitive pricing stems from our extensive experience with Regulatory Authorities, our experienced employees and our understanding of the Medical Device Industry. We want to have a long term business relationships with our customers and want them to be completely satisfied with us. That is why we strive to be the best in the Industry.
Even for all your complex cases, we have a network of Consultants working in tandem with our in-house regulatory professionals for end to end solutions. We also have comprehensive packages for those Clients who would like to obtain multiple services from us, making it cost effective for you.
Our Services include:
- Risk Assessment
- Quality system regulation
- Design controls
- Validation
- Project management capabilities
- Preparation of FDA Registration and Listing
- Assistance with Regulatory Strategies and Assessment
- Liaison with FDA for Pre-submission or Special Meetings
- Assistance with FDA's Requirements for Sponsors, Monitors, and Clinical Investigators
- Guidance in Development of Briefing Package for FDA Meeting
- Assistance with Submission Equivalence (SE)
- 510(k), Investigational Device Exemption (IDE), Pre-Market Approval (PMA) Preparation and/or Assistance
- Preparation and/or Assistance with Submission Amendments and Supplements as well as Required Reporting Records
- Development of Strategies for Advisory Committee Meetings
- Assessment and Development [regulatory and design control] of Strategies
- Protocol Development/Study Monitoring/GCP Audit
- Report and Summary Preparation
- Protocol Development
- Assistance with FDA’s Good Manufacturing Practices (GMP) set forth in the Quality System (QS) regulation
- Develop appropriate enforcement action responses and/or corrective action plans in response to FDA 483s and warning letters
- Develop effective product recall strategies, including notification to applicable regulatory agencies and customers
- Assist with post-market surveillance to address complaint handling-including MDRs (Medical device Reports), failure investigation, problem reporting, and device tracking
- FDA pre- IDE support
- Comprehensive regulatory support services
Call us today our Kansas office to know what we can do for you at 913-845-3851 between 8AM and 5 PM or fill out our contact form and we will get in touch with you directly.
