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Quality & compliance

Many regulatory agencies around the world have recently announced initiatives that include more stringent quality requirements, a higher volume of inspections, and swifter, heavier penalties for non-compliant medical device manufacturers. Compliance issues among manufacturers are becoming rapidly more visible as smaller, less sophisticated manufacturers are consolidated into larger and larger companies.

Manufacturer shall establish Quality Management System (QMS) and demonstrate compliance before regulatory approvals. Different countries require manufacturers to demonstrate compliance to the regulation that is applicable to that country where the products are intended to be marketed. Some examples are:

  • Europe: Directive 93/42/EEC: Medical Device Directive (MDD) and ISO 13485, ISO 9001
  • FDA: 21CFR part 820 – Quality System Regulation (QSR)/Good manufacturing practices (GMP)
  • Canada: Canadian Medical Device Regulations (CDMR), SOR/98-282
  • Japan: Pharmaceutical Affairs Law (PAL)
  • China, Australia, Korea, and others: As of now accepts ISO 13485

We provide the following consulting services:

Quality Management system Development and Implementation (ISO 13485)

We will work with your company to identify necessary procedures and product-specific needs and develop and deploy customized standard operating procedures (SOPs). Additionally we will work on client specific needs such as:

  • Quality manual
  • Quality policy and objectives
  • Employee training for QMS

Quality Systems regulation (FDA – QSR; 21CFR part 820)

  • We will work with you to identify necessary procedures and product-specific needs and develop and deploy customized standard operating procedures (SOPs).
  • We can also implement dual quality systems for EU (ISO 13485) and FDA (QSR; 21CFR part 820), based on client’s needs.

Manufacturing compliance

We provide day to day operational support to quality and compliance groups. Some examples are:

  • Manufacturing process scale-up and necessary validations.
  • Test method development and validation.
  • Manufacturing transfers and necessary validations.
  • Manufacturing materials/equipment/process changes.

Post market or post production compliance

We provide day to day operational support to post production or post market compliance:

  • Non-conformances
  • Corrective and preventive actions.
  • Product hold orders and field corrective actions.
  • Response to FDA warning letters, 483, and notified body findings.

Microbiology compliance

We will work with your manufacturing facility to identify the needs and support as needed. Some examples are:

  • Microbial monitoring.
  • Environmental monitoring.
  • GLP compliance of test labs.
  • Test method validation.
  • Prepare responses for notified body queries.
  • Represent company as a technical expert during meetings with notified bodies.

Material and Supplier change management

We will support qualifying new suppliers, evaluating current suppliers and material changes.