<ul><li>Is a suite   of independent  allied  Medical Device Industry Professionals   & Consultants linked and working toge...
Summary of Services Medical DDM, Inc.   Medical Device Development & Mfg. Outsourcing Need: Legal Business Formation &  In...
Medical DDM, Inc.   Medical Device Development & Mfg. Medical  Device Design Disposable/Consumables Design  & Prototyping ...
Medical DDM, Inc.   Medical Device Development & Mfg. <ul><li>Strategic Regulatory Planning </li></ul><ul><li>FDA Submissi...
Medical DDM, Inc.   Medical Device Development & Mfg. Trial Reporting & Submission Biostatistics Data  Management Trial  M...
<ul><li>Thermoplastic Injection Molding  and Tooling  </li></ul><ul><li>LIM Silicone & Elastomer Molding  and Tooling  </l...
<ul><li>Contact us at:  </li></ul><ul><li>Medical DDM, Inc. </li></ul><ul><li>16 Nice </li></ul><ul><li>Laguna Niguel, CA ...
 
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Medical Device Development And Manufacturing Presentation

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Medical Device Development And Manufacturing Presentation

  1. 1. <ul><li>Is a suite of independent  allied Medical Device Industry Professionals   & Consultants linked and working together to: </li></ul><ul><li>support FOCUSED innovation & DESIGN </li></ul><ul><li>and rapid development of medical devices </li></ul><ul><ul><ul><ul><li>from early concept research development & prototyping </li></ul></ul></ul></ul><ul><ul><ul><ul><li>to production ready CAD design </li></ul></ul></ul></ul><ul><ul><ul><ul><li>To and through regulatory milestones, pathways, validations, and verification </li></ul></ul></ul></ul><ul><li>all the way to & through commercialization . </li></ul>Medical DDM, Inc. Medical Device Development & Mfg. Medical DDM, Inc. Medical Device Development & Mfg:
  2. 2. Summary of Services Medical DDM, Inc. Medical Device Development & Mfg. Outsourcing Need: Legal Business Formation & Intellectual Property Commercial Manufacturing & Assy. Regulatory & Clinical Trial Management Device Design & Development
  3. 3. Medical DDM, Inc. Medical Device Development & Mfg. Medical Device Design Disposable/Consumables Design & Prototyping Software Design Electronic Inst. & Hand Held Design
  4. 4. Medical DDM, Inc. Medical Device Development & Mfg. <ul><li>Strategic Regulatory Planning </li></ul><ul><li>FDA Submissions </li></ul><ul><li>510K Submission </li></ul><ul><li>PMA Premarket Approval Application </li></ul><ul><li>IDE Investigational Device Exemption </li></ul><ul><li>Master files </li></ul><ul><li>Design dossiers </li></ul><ul><li>Technical documentation and files </li></ul><ul><li>Combination products </li></ul><ul><li>HUD Humanitarian Device </li></ul><ul><li>HDE Humanitarian Device Exemption </li></ul><ul><li>MDR Medical Device Reporting </li></ul><ul><li>PDP Product Development Protocol </li></ul><ul><li>Complaint handling </li></ul><ul><li>Labeling </li></ul><ul><li>Interpretation of standards and guidelines </li></ul><ul><li>Agency Support & Representation for </li></ul><ul><li>Regulatory Agency Meetings and Panels </li></ul><ul><li>Postmarket surveillance protocols </li></ul><ul><li>Postmarket reporting </li></ul><ul><li>Registration and licensing </li></ul><ul><li>Import certificates and registration </li></ul><ul><li>Expert reports </li></ul><ul><li>Export certificates and registrations </li></ul><ul><li>Vigilance reporting </li></ul><ul><li>EU Directives </li></ul><ul><li>CE Marks </li></ul>Regulatory Affairs Consulting
  5. 5. Medical DDM, Inc. Medical Device Development & Mfg. Trial Reporting & Submission Biostatistics Data Management Trial Management Trial Design Strategic Planning Clinical Trial Consulting
  6. 6. <ul><li>Thermoplastic Injection Molding and Tooling </li></ul><ul><li>LIM Silicone & Elastomer Molding and Tooling </li></ul><ul><li>Automated & Manual Assembly & Packaging </li></ul><ul><li>Sterilization </li></ul><ul><li>FDA regulated and audited facilities </li></ul><ul><li>- ISO 13485 certified facilities </li></ul><ul><li>- ISO 9001 certified facilities certified </li></ul><ul><li>- cGMP compliant facilities </li></ul><ul><li>- SPC/SQC compliant facilities </li></ul>Medical DDM, Inc. Medical Device Development & Mfg. Commercialized Production Assembly, Sterilization, Packaging Domestic & International
  7. 7. <ul><li>Contact us at: </li></ul><ul><li>Medical DDM, Inc. </li></ul><ul><li>16 Nice </li></ul><ul><li>Laguna Niguel, CA 92677 </li></ul><ul><li>949.499.9911 Office </li></ul><ul><li>714.749.9306 Mobile </li></ul><ul><li>[email_address] </li></ul><ul><li>www.medicalddm.com </li></ul>Medical DDM, Inc. Medical Device Development & Mfg. Medical DDM, Inc. Medical Device Development & Mfg.
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