Hi,

There are two stages in developing a medical product.

1. Designing to comply with certain standards and sell it as such, claiming "...complies to XXX".

2. The next stage is to get certified by an approved test lab. For your information not all labs are accredited. The process is very costly. Third party certification is a must in lot of countries. I was told that the awareness is catching up in India, especially with opening up of Insurance industry.

One consolation is lab equipment standards are not as stringent as other medical devices, but definitely stringent than other commercial products.

As the subject very involved it may not be appropriate to continue here in due consideration for other members.