Medical Device Manufacturers - ISO 13485

If you are a Medical Device Manufacturing company, you will most likely need to comply with:

• ISO 9001 Medical Devices (non manufacturers)

• ISO 13485 Medical Devices (manufacturers)

• FDA QSR / 21 CFR 820

we can then provide you with the templates, systems and consulting services to ensure your compliance.

How to implement an ISO 13485 Quality System

We have an affordable and practical approach to successfully implement quality systems like ISO 13485 systems. Templates and consulting services can be provided to meet the needs of small / medium size medical device manufacturing companies.

These systems ensure compliance to the TGA’s and FDA's requirements, companies typically complete registration to ISO 13485 within 6 to 12 months. PharmOut will help clients achieve registration on schedule. By installing quality systems that will generate hard-dollar savings / improvements and operate with minimal costs and you will reap the rewards sooner.

Status of the standards

The ISO 13485:2003 Standard was effective July 15, 2003.

The following standards will expired July 15, 2006 ISO 13485:1996 / ISO 13488:1996.

ISO 13485, supersedes EN46001/2 for Medical Devices. In essence the procedure for certification is the same as that for ISO 9001 (as this scheme is based on the prime document ISO 9001.