Medical Device Quality Systems

ISO 13485/ CFR 820 Medical Devices

Quality Management Systems for Medical Devices

SeerPharma provides expert advice to Medical Device companies wishing to upgrade their quality systems to full ISO13485 and or US FDA CFR 820 compliance.

Typically clients are wanting to move from a document driven ISO9000 based system to a regulated ISO 13485/CFR820 evidence based system.

The program of services available is divided into four areas:

• Gap Analysis – system compliance with ISO 13485 and CFR 820
• The Documented System - Quality Policy, Manual and Procedures
• Development of Quality Procedures to meet Medical Device standards
• Implementation, Training and Auditing of the developed system

Gap Analysis

The gap analysis establishes the extent of assistance needed by:

• Verifying the current status and compliance of the quality system
• Establishing the areas where a gap exists compared to ISO13485/CFR820
• Forward strategy to close the gap in the most cost effective and practical manner

The following diagram illustrates the additional emphasis of CFR 820 and ISO 13485 over ISO 9001. Our gap analysis focuses on these critical areas.

The Quality System consists of documents, auditing and monitoring processes. The elements of the system are shown in the following diagram.

Developing Quality Procedures

The manner in which SeerPharma approach development, is firstly by asking how a particular operation is undertaken and then verify if that operation needs to be documented or not . In some cases operations may already be documented but will need upgrading to comply with the requirements of ISO 13485/CFR 820.

The procedures will be drafted by either SeerPharma or the individual company subject matter experts. These procedures once developed are reviewed for accuracy and conformity. All personnel involved with the particular procedure are educated in how the activity is to be performed, the reason why it is to be carried out and any other individual issues or misunderstandings which need to be resolved.

Implementing Quality Procedures

The implementation of Quality Procedures involves training key personnel in the application of the procedure. The use of follow up gap auditing determines if an implemented procedure is being followed and more importantly becomes effective and improves compliance.