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ISO 13485 Consulting
Our products are designed so that you can use them as a do-it-yourself implementation tool. However, we know that sometimes you might want to consult an expert to help you on your project for a portion of it.
We recommend the following consultants:
Aesthetica Tech
Aesthetica-Tech - Medical Device Consulting for Regulatory & Clinical Affairs
Aesthetica-tech regulatory consulting will develop and implement a competitive and cost effective regulatory strategy, prepare and submit marketing application, and serve as your liaison from start to finish, helping you prepare for and respond to regulatory agency questions. For both professional and consumer devices.
Our Services Include:
*FDA regulatory document preparation and submission 510(k)
*Establishment registration and Device Listing
*Certificate of Foreign Government
*Assistance with Medical Devices saftey testing, evaluation, and certification, to standards such as IEC 60601-1, CB Scheme
*ISO Consulting
*U.S. Agent
Methodize, Inc.
- Methodize Inc. has over 35 years of combined Regulatory, Quality, and Clinical services.
Internationally recognized, Methodize Inc. has helped companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market.
- Our mission is to provide our clients knowledge, integrity, and services to successfully take their products to market.
- We are located in Minneapolis, MN and provide our products and services to countries and industries around the world.
Areas of Expertise
- CE Marking Consulting
- ISO 13485 & ISO 9001 Certification
- ISO 14971 Risk Analysis
- Clinical Trials US
- EU & International
- Authorized European Representative
Services
- Phone consulting
- On-site consulting
- Training
- Internal Auditing
- 3 Hour Consulting Package, available with purchase of the Small Business Package or the All-in-One Package,
- 6 Hour Document Review Package,
Contact
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