The Auditing Group, Inc. (TAG) - Our Medical Device Subject Matter Experts have the experience in thousands of Medical Devices and Combination Device (Device/Drug and Device/Biologics), from Class I, II and Class III.
We have extensive experience with EU Directives 745/2017 for Devices and 746/2017 for IVDD Directives and ISO 13485 QMS and 14971 Risk Management. Specializing in Quality Management Systems (QMS) to satisfy 21 CFR Part 820 Quality Regulations.
- Medical Device QMS Audit and Training (Part of cGMP Compliance Program)
- Medical Device Master Record (MDR) Review
- Design History File (DHF) Audits
- Device History Records and Assembly Record Audits
- Design Engineering Review and Analysis
- Equipment Qualifications and Validation
- Facility Qualifications
Have you Audited your Device Files and your QMS Capabilities?
All of our Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by the TAG, ASQ and Global Accepted Certifications!
You purchased the handbooks from GMP Publications and now what?
1. Do you have the resources to conduct proper training against the Regulations based upon applicability?
2. Have you conducted a formal Gap Analysis against the Regulations?
If not, consider TurnKey QMS and The Auditing Group, together assisting firms to meeting and exceed GMP requirements.
Do you need to?
First, Understand the FDA Thinking;
If products, or services, or any action, in whole or in part, which may impact either directly or indirectly, is distributed, adhered, affixed, consumed, or used by a Consumer or Patient, either by Use, Ingestion, Injection, Inhalation, and/or Permeation, they must follow GMPs, or…
If a product is manufactured, or services rendered which greatly benefits the safety, health or welfare of a consumer or patient, directly, and/or indirectly, or…
If a Product or Data which may influence, form a decision for, or create an adverse reactionary event to the health, safety, welfare of a Consumer or Patient, directly or indirectly;
You must comply to the GMPs!
So, what is a Product? What are Services? What are Data? What is direct and/or Indirect impact?
Your applicability to the Federal Regulations is based upon the Product, Service or Data that you provide. And the question is, what is your applicability, directly and/or indirectly?
And this is the hardest concept to understand.