ISO 13485 for Medical Device Manufacturers
If you are a Medical Device company, trying to comply with:
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ISO 13485 Medical Devices, or
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QSR / 21 CFR 820
we can provide you with the templates, systems and consulting services to ensure you comply.
Regulatory knowledge, practically applied
We have an affordable and practical approach to implementing ISO 13485 systems. Templates and consulting services can be provided to meet the needs of small/medium size medical device manufacturers.
Most companies achieve compliance to ISO 13485 within 6 to 12 months. PharmOut will help you achieve registration on schedule. By installing quality systems that will generate hard-dollar savings / improvements and operate with low maintenance costs and you will reap the rewards sooner.
Status of the standards
The ISO 13485:2003 Standard was effective July 15, 2003.
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").
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Validation
GMP Compliance
Drug / Medical Device Registration
