FAQ’s

How long have you been in business?

Regulatory Specialists, Inc. was started in 1989 by Greg Holland.

How many consultants do you have?

We have approximately 75 consultants that represent Regulatory Specialists, Inc. Each has their own areas of specialty and expertise.

What are your areas of specialty?

We focus on the medical device, IVD, pharmaceutical, biologic and diagnostic markets. Within these markets, Regulatory Specialists, Inc. is able to assist with products of all classifications and regulatory requirements. We have experience in a wide variety of projects, from tongue depressors to mechanical heart implants.

Where are you located?

Regulatory Specialists, Inc. is headquartered in Irvine, CA. Our consultants are located all over the world: California (southern and northern), Illinois, New York, Florida, Maryland, Colorado, New Mexico, Michigan, Mexico, Italy, Switzerland, and Taiwan.

What class is my product?

There are several classification systems (FDA, Health Canada, and European Union) that have unique classification numbering systems. Each product falls into one of these classifications. Regulatory specialists, Inc. can assist you in performing a formal classification of your device.

Do I have to have a quality system?

A well written quality system is a benefit to all companies, producing more consistent product and saving money. Not all companies are required to maintain a quality system. Regulatory specialists, Inc. can assist you in performing a formal classification of your device. A product classification will document the regulatory requirements of a quality system.

What if I contract out manufacturing?

If you are maintaining a quality system, it is easier if you contract out to a manufacturer who also maintains a quality system. This will make auditing them as a vendor seamless. If you have a non-quality system contract manufacturer, then the regulatory authorities may need to audit them in addition to your regular audits.

Do I need a 510(k), or PMA?

There are several classification systems (FDA, Health Canada, and European Union) that have unique classification numbering systems. Each product falls into one of these classifications and the classification determines if a FDA 510(k) or PMA is required. Regulatory specialists, Inc. can assist you in performing a formal classification of your device as well as preparation of any submission documentation.

Do I need a CE Mark?

To market our medical device in the EU a CE Mark certification is required. Regulatory specialists, Inc. can assist you in performing a formal classification of your device as well as preparation of any technical file or design dossier.

Do I need a 13485 certificate?

For sales into Canada, the EU, or many other international countries, a formal ISO13485 certification is required. Regulatory Specialists, Inc. can assist with the creation of the ISO13485 compliant quality system as well as management of the Notified Body who will perform the formal certification.

What is the Health Canada process to sell in Canada?

The first step is to classify the product. If the product is Class II, III, or IV, then the second step is to implement an ISO13485 including CMDCAS quality system and have it certified. Third, an MDL application is needed to cover the device. Fourth, an MDEL application is needed to cover the establishment. Licenses do not expire, but annual fees are due to Health Canada. Regulatory Specialists, Inc. can assist with all the steps in establishing a system, obtaining licenses, and maintaining licenses for the Canadian market.