Quality Management System
Requirements :
“Regulatory compliance” often includes maintaining a quality management system. Effectiveness of quality management system is statutory requirement, those are involved with medical device design, manufacture, assembly, contract sterilization, installation, relabeling, remanufacturing, repacking, specification development, and initial distribution. The Federal Regulation 21 CFR Part 820 Quality System Regulation (QSR) defines the quality system requirements that apply to medical device manufacturers. The FDA is responsible for periodic inspection to verify QSR compliance of all medical device companies.
IPSurface can help you with your medical device regulatory needs. Knowing and interpreting regulations and guidelines, and having the right strategy, the right data, and the right presentation is important for expeditious review and FDA approval of your medical device. The following are some of the key regulatory consulting services we provide. In addition, we would be happy to discuss any of your specific regulatory needs.
- Develop regulatory strategy for medical device development, pre-market submissions, and FDA review.
- Provide interpretation of applicable medical device regulations and guidance document requirements. Assist with preparation and provide pre-submission review of pre-market notification [510(k)], investigational device exemption (IDE), pre-market approval (PMA), and humanitarian device exemption (HDE) applications.
- Regulatory due diligence
- Assist with product labeling and Instructions for Use (IFU) development and provide pre-submission review to ensure regulatory requirements are met.
- Initiate, coordinate, and participate in meetings with FDA to discuss regulatory, scientific, and or technical issues.
- Manuscript drafting, drafting of white papers
- Literature reviews
- Assist with medical device import and export requirements.
- Assist with registration, listing, and reporting requirements.
- US Agent Services for foreign medical device manufactures
- Establishing/Evaluating QSR/ISO Compliant Quality Systems
- Modifying Quality System to Include FDA/ISO Requirements
- Authoring Quality Manuals, Policies and Procedures
- Developing Work Instructions and Process Flow Diagrams
- Establishing Medical Device Reporting Procedures
- Ensuring Appropriate Design, Change and Document Controls
- Device Master Records and Device History Records
- Design History Files
- Quality System Gap Analysis/Audit
- Complaint Handling and Investigations
- Corrective and Preventive Action (CAPA) Procedures
- Paper-Based and Software-Driven Quality Systems
- Quality Objectives and Management Reviews
- Quality System Training
- Supplier Quality Audit (Suppliers/Sterilizers/Manufacturers)
- Stability Studies
- Biocompatibility services
- PRRC cervices
- Regulatory due diligence
- Manuscript drafting, drafting of white papers
- Literature reviews
- Expert witness services
- US Agent Services for foreign medical device manufacture
Medical Writing
Our skilled medical writers offer a range of services, including preparation of regulatory documentation, clinical evaluation reports, scientific manuscripts, and more, to support successful submissions and product launches.
Regulatory Consulting
We provide comprehensive regulatory consulting services, guiding clients through the maze of regulatory requirements to achieve compliance and obtain necessary approvals for their medical devices.
Intellectual Property Consulting
Protecting intellectual property is crucial in the competitive medical device industry. Our consultants offer strategic advice on patent applications, patent searches, and intellectual property management.
Certificates
