The First Post

Back in April 2010, after working for 25 years with the same company, I decided to do what I know best through my own business. I set up a company which I called 'Quality Mark Consultants Limited' consulting in Quality and Regulatory Affairs for the Medical Device Industry. My particular area of expertise lies within in-vitro diagnostic (IVD) Medical Devices. These tend to be kits for the testing of patient samples for use in the laboratory or the home. The aim being to use the test results to diagnose, or more typically to aid in the diagnosis of, conditions or diseases. The most commonly known of this type of product is the bulk standard pregnancy test.


The products are regulated in most countries, so companies need to demonstrate that they meet a number of requirements before they can sell a particular product in that territory. In addition, there are regulations that specify how the production of these products must be controlled in order to ensure that products continue to meet these requirements.


My company specializes in helping clients to meet these quality and regulatory requirements in the most user friendly way - that is, without bringing the business to a standstill. We can help our clients with the following:

• Development of Regulatory Strategies for their business and products that derive from the long term business plans. This would include finding the quickest regulatory route to get new products to market and at the lowest cost.


• Regulatory submissions- providing assistance so that clients can get it 'right first time' with the regulatory authorities.
  


• Quality System Planning to fit with both existing and new product strategies
  


• Preparations for upcoming regulatory inspections

If a company has had problems with regulatory authorities, then we can also help to get those sorted out and the company back in the regulator's good books.

We like to work with companies of any size - but particularly with small start-up companies trying to bring through their first products.

Our philosophy is that regulatory and quality processes should add value to the business as well as ensuring compliance to regulations. So we will always take the most pragmatic and least burdensome approaches in order to deliver both customer satisfaction and regulatory compliance.

If you would like to learn more about us, or think that we may be able to assist you, please give me call or drop me an email at the address below.

Thanks for reading my first ever Blog !

Mark Gittins

Director & Principal Consultant

Quality Mark Consultants Limited

email: mark@qmcl.co.uk

mobile: +44 (0) 7714 207 524