OAR Tool & Die - Providence, RI | Medical Device Consulting Services

OAR MEDICAL
Medical Device Consulting Services

OAR Medical can provide cost-effective medical device regulatory consulting services in addition to assisting you with design, manufacturing and packaging of your product.

OAR Medical’s staff has over 30 years of experience with a variety of medical products and technologies which enable us to develop creative approaches to reach your goals of successfully introducing your products in the United States, Canada, and Europe.

Regulatory Consulting for U.S. FDA, Canadian, and European Requirements
Clinical Trial Design and IDE Submissions
Quality System Development and Implementation
Internal Audits
U.S. Agent and Foreign Agent
CE Mark Consulting Services
510(k) and Technical File Assistance

KEY REGULATORY SERVICES

Developing and Implementing Regulatory Strategies:

Assess impact of regulatory environment and FDA policies
Design pre-clinical and clinical studies
Communicate and meet with FDA

Preparing and Submitting Regulatory Documents:

Investigational Device Exemption (IDE) applications
Pre-market notifications [510(k)s]
Device reclassification petitions
Risk Analysis and FMEA
Master files
Canadian device license applications
Technical files for EU marketing

Reviewing and Developing Instruction Manuals and Other Labeling for FDA Compliance:

Providing Liaison with FDA
U.S. Agent Services
European Regulatory Consulting
CE Mark Consulting Services
Contacts with European Authorized Representatives

Preparing for CE Marking:

Product classification and essential requirements determination
Labeling reviews
Risk management
Design Dossiers and Technical Files
Liaison with Notified Bodies and Competent Authorities

Validation Services:

Biocompatibility tests to ISO 10993
Shelf Life Studies
Accelerated Aging
Package Stability
Shipping Tests (ISTA standards)
Sterilization Protocols (Steam, Gamma, EtO)

MEDICAL DEVICE PRODUCT EXPERIENCE

Biocompatibility tests to ISO 10993
Combination Drug/Device Products
Anesthesia / Respiratory
Blood Bank
Cardiovascular
Gastroenterology & Urology
General Hospital
General Surgical
Infection Control
Neurology
Obstetrics & Gynecology
Ophthalmology
Orthopedics
OTC (over-the-counter) Devices
Physical Medicine
Plastic Surgery
Radiology
Ultrasonics
Wound Healing

Please contact us by calling (401) 781-2352 or use our Electronic Quote Form if you require medical component prototyping or production manufacturing and assembly.


	OAR Tool & Die is ISO 9001:2000 certified. Click here for information about our certification and regulatory compliance