Post on 22-Nov-2014
description
Is a suite of independent allied Medical Device Industry
Professionals & Consultants linked and working together to:
• support FOCUSED innovation & DESIGN• and rapid development of medical devices
– from early concept research development & prototyping– to production ready CAD design– To and through regulatory milestones, pathways, validations, and
verification
• all the way to & through commercialization.
Medical DDM, Inc. Medical Device Development & Mfg.
Medical DDM, Inc. Medical Device Development & Mfg:
Summary of Services
LegalLegalBusiness FormationBusiness Formation
& & Intellectual PropertyIntellectual Property
CommercialCommercialManufacturing & Assy.Manufacturing & Assy.
Regulatory & Clinical Regulatory & Clinical Trial ManagementTrial Management
Device Design&
Development
Medical DDM, Inc. Medical Device Development & Mfg.
Outsourcing Need:
Medical DDM, Inc. Medical Device Development & Mfg.
Medical Device Design
Disposable/Consumables Disposable/Consumables
Design Design & Prototyping& Prototyping
Software Design
Electronic Inst. & Hand Held Design
Medical DDM, Inc.
Medical Device Development & Mfg.
•Strategic Regulatory Planning•FDA Submissions•510K Submission •PMA Premarket Approval Application •IDE Investigational Device Exemption •Master files•Design dossiers•Technical documentation and files•Combination products•HUD Humanitarian Device •HDE Humanitarian Device Exemption •MDR Medical Device Reporting •PDP Product Development Protocol
•Complaint handling•Labeling•Interpretation of standards and guidelines•Agency Support & Representation for Regulatory Agency Meetings and Panels •Postmarket surveillance protocols•Postmarket reporting•Registration and licensing•Import certificates and registration•Expert reports•Export certificates and registrations•Vigilance reporting•EU Directives•CE Marks
Regulatory Affairs Consulting
Trial Reporting& Submission
Biostatistics
Data Management
Trial Management
Trial Design
Strategic Planning
Clinical Trial Consulting
Medical DDM, Inc. Medical Device Development & Mfg.
• Thermoplastic Injection Molding and Tooling • LIM Silicone & Elastomer Molding and Tooling • Automated & Manual Assembly & Packaging• Sterilization
• FDA regulated and audited facilities• - ISO 13485 certified facilities• - ISO 9001 certified facilities certified• - cGMP compliant facilities• - SPC/SQC compliant facilities
Medical DDM, Inc. Medical Device Development & Mfg.
Commercialized ProductionAssembly, Sterilization, Packaging
Domestic & International
Contact us at:
Medical DDM, Inc.
16 Nice
Laguna Niguel, CA 92677
949.499.9911 Office
714.749.9306 Mobile
Rich.Brock@Medicalddm.com
www.medicalddm.com
Medical DDM, Inc. Medical Device Development & Mfg.
Medical DDM, Inc. Medical Device Development & Mfg.
all the way through to
commercialization
Medical DDM16 Nice
Laguna Niguel, CA 92677
949.499.9911
www.medicalddm.comRich.Brock@MedicalDDM.com
Early Stage Involvement
Medical DDM
Medical Device Development& Manufacturing
Mechanical&
Industrial Design
ElectronicInstrument &
Hand Held Design
SoftwareDevelopment &
Design
CommercializationDevice DesignPrototyping &
Validation
Legal,Regulatory,Clinical Trial
GlobalContract
Manufacturing&
Assembly
Medical DDM
Medical Device Development& Manufacturing
A Suite of specialized DeviceDesign Service Providers linkedand managed by project for Fast,
Flexible, and Focused results
Focused Flexible
Fast
Focused
Fast
Flexible
Macro Fluidic Devices & Micro FluidicInterfacesElectro-Medical DevicesLab on a Chip DevicesMedication Delivery DevicesCombination Product DevicesDiagnostic CartridgesSurgical DevicesMonitoring DevicesHospital Equipment DevicesOcular DevicesBio-Assay DevicesVascular Intervention DevicesDisposable High Volume ConsumableDevices