ISO Compliance
RQS can design a quality system that meets the demands of:
- ISO 9001-2008, ISO 13485-2012 and ISO-13485-2016
- Canadian Medical Device Regulations
- European Medical Device Directive (MDD)
ISO 9001 and 13485 are “best quality practice” requirements recognized in most major markets including the US, EU, Canada, Australia, Japan, Taiwan and China.
Your company will be able to expand and or continue existing business opportunities in ISO 9001 and 13485 countries where certification is a contractual obligation or expectation. This will also assist you where countries have reciprocal agreements where compliance in one country will be accepted by another.
RQS will assist you in establishing a quality system which helps your company implement its strategic goals as well as satisfies the rigors of an independent external audit, stressing safety, regulatory and quality concerns specific to the medical device industry.
Once your quality system is in place, RQS will help you select a registrar or certifying body and will help you through your registration audit and ensuing surveillance audits. RQS will also be able to help you register your products in those countries where you do business.
ISO compliance:
- ISO 9000:2008
- ISO 13485-2012
- ISO-13485-2016
- Canadian Medical Device Regulations
- European Medical Device Regulations
- Australia Medical Device Regulations
