ISO 13485 for Medical Device Manufacturers

If you are a small to medium-sized Medical Device company, trying to comply with:

ISO 9001 Medical Devices
ISO 9001 for Pharmaceutical and Biotech
QSR / 21 CFR 820

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

Introduction

We have an affordable and practical approach to successfully implement 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 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. Our policy of practical implementations of Quality Systems for Pharma and Medical Device Manufacturers?

Did you know that independent studies reveal that companies embracing Quality Improvement Programs perform better than those that don’t?

Status of the standards

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

The following standards will expire 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, hence it is sometimes called " ISO 9001 Medical Devices").