Product Development 

We provide complete engineering and regulatory compliance solutions to companies, surgeons, or anyone wanting to get a medical device to market.

3D printing of components 

•  Product development from concept to end user

• Machine shop, injection molding, and cleanroom assemblies

• Concept Brainstorming & Product Development

• SolidWorks 2019 Modeling and Drafting


• Prototyping

• Component Sourcing

• Specifications (Components & Assemblies)

• Verification Testing & Reports

• Packaging Design & Validation

• IP Research

• Documentation

• Quality System (Auditing, SOP Revision, Systems Implementation, Training)

• Design Validation

• Design Reviews

• Risk Analysis

• Design FMEA

Quality and Regulatory Affairs:

-Over 180 successful 510k Submissions & PMA’s

- International submissions and compliance, CE, EU, Health Canada, Australia, China


-Create and Review Product Change "Letters to File"

-FDA Facility Registration and Device Listing 

-FDA Good Manufacturing Practices (GMP), Quality System 

-FDA Quality System Audit Inspection Support 

-Medical Device Directive Compliance and Support 

-Medical Device Reporting and Complaint System Compliance 

-Quality and Regulatory Affairs Management

-ISO 13485-2016 Certification

Project Business Development

     We will build your project business plan and action plans

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Product Development

Complete Engineering Services

CAD Models and Drawings on SolidWorks 

3D Printed Prototyping

Injection Molding, CNC Machining 

Packaging and Sterilization 

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Regulatory Affairs

FDA ,CE  and International Submissions

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Electrosurgical and disposable  Products

Benjamin R.

Online Co.

Orthopedic Implants, Catheters, Monitors, Diagnostic Systems

Brick & Mortar Retail Co.

FDA, CE , International Regulatory Submissions and  Compliance

Truly Services LLC