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:

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 .

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

Medical DDM, Inc. Medical Device Development & Mfg. Medical Device Design Disposable/Consumables Design & 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

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

Medical DDM, Inc. Medical Device Development & Mfg. Trial Reporting & Submission Biostatistics Data Management Trial Management Trial Design Strategic Planning Clinical Trial Consulting

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 Production Assembly, Sterilization, Packaging Domestic & International

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

Contact us at: Medical DDM, Inc. 16 Nice Laguna Niguel, CA 92677 949.499.9911 Office 714.749.9306 Mobile [email_address] www.medicalddm.com Medical DDM, Inc. Medical Device Development & Mfg. Medical DDM, Inc. Medical Device Development & Mfg.

Contact us at:

Medical DDM, Inc.

16 Nice

Laguna Niguel, CA 92677

949.499.9911 Office

714.749.9306 Mobile

[email_address]

www.medicalddm.com