Working with Management

Anzil works with the Management to train on various responsibilities for implementing and maintaining the QMS as well as works with the Technical & Quality Assurance team to complete procedures, forms & templates including how to document and record information.

Anzil covers all the product-specific requirements for all components, manufacturing processes, verification & validation along with corrective and preventative actions (CAPA) for assessing customer satisfaction, product non-conformance, assessing and improving quality policies and procedures, carrying out and assessing the results of internal audits, and implementing systems for continuous improvement. We work with clients to make the QMS simple yet effective and flexible to allow changes in order to keep up with the changing regulatory requirements.

Quality Management Systems

  • Management Controls
  • Design Controls
  • Production & Process Controls
  • Corrective & Preventive Action
  • Change Management
  • Product Surveillance

Anzil Meditech works with Class I, IIA, IIB & III medical device companies to develop/revamp the QMS to ensure complete product safety & efficacy.

  • Anzil develops comprehensive Quality Management Systems as per USFDA requirements of 21 CFR Part 820 as well as ISO 13485.
  • Anzil works with medical device companies to integrate quality & regulatory requirements using a risk-based approach.
  • We have developed our own structured system of procedures, templates, forms, and processes covering all aspects of design, manufacturing, risk management, document control, product labeling, supplier management, complaint handling, and more.
  • Implementation of QMS plays a vital role and must be done thoroughly to ensure safety, efficacy & high quality with repeatability. There is a common misconception that a quality management system is to be implemented only during the production stage.
  • However, working with Anzil would ensure that the customer would implement QMS from product development to post-production. QMS Systems such as Design Control, Risk Management, Document Control, Records Management & Supplier Management is implemented in the product development stage to ensure a smooth transition into the production phase.
  • A robust post-production quality management system must be implemented to enable effective documentation & follow up of customer complaints & feedback.