ISO 13485 Costs

For many companies, the decision to implement ISO 13485 depends on the answer to this simple question: Is the sales potential for the product in Europe, Canada, Australia or Japan worth the cost of obtaining and maintaining ISO 13485 certification?

How much does it cost to obtain ISO 13485 certification?

To assist in that process, we have attempted to give you a very broad yet realistic sense of your estimated investment in obtaining ISO 13485 certification. In general, a smaller to mid sized company with one location that is not manufacturing high risk devices can expect to spend about US$30,000-$45,000 for all ISO 13485 costs which includes:

• QMS consulting fees to assist with ISO 13485 document preparation, training, and implementation over the course of 4-7 months
• ISO 13485:2003 certification audit by an authorized Notified Body, Registrar, Registered Certification Body or Conformity Assessment Body

Companies that choose to complete more of the ISO 13485 work in-house may spend less upfront cash, but doing so often extends the length of the ISO 13485:2003 certification process and requires significant employee resources that must be diverted form other tasks while the implementation is taking place. While it may seem costly to hire an experienced ISO 13485 consultant, the additional cost is often negated by the fact that your product will be available for sale in the market much sooner and thus generating revenue for your company.

In any case, Emergo Group does not estimate ISO 13485, we give you a fixed cost for the total project so you will know exactly how much you will spend. As part of the implementation, we will also assist you in obtaining ISO 13485:2003 certification audit proposals from Notified Bodies so you will understand precisely how much of an investment is required. Read more about how long it takes to implement ISO 13485.

Please contact us for more information or a free proposal on implementing ISO 13485 at your company.