Quality is the backbone of every business

Quality is a broad term and concept which is central to all companies and anyone who delivers a product or service.

Quality is the backbone of every business. Quality is what creates your reputation, word of mouth and repeat business. The quality system or “Way of Working” Also ensure that you are compliant with the regulations. MDR QSR, IVDR all requires you to have an implemented quality system!
Because of it’s importance, there there needs to be a high level of focus on procedures and documentation around quality management, product and project inall companies.

We can assist you in all areas of quality assurance and quality compliance

Our company have helped many companies to get through this ranging micro up to multinternational companies. Our experience helps the companies to focus on what is important at what stages. Typical the systems comes last on the priority list…

identify requirements

The first point to ensure Quality compliance is to find all external requirements that are applicable for your quality system. Even though most requirements are similar there are different ways to view them. What Notified Body to use, shall you have MDSAP audit and what is an effective quality management system. All starts with what requirements you must meet, QSR for US, ISO 13485, ISI 14001 might be a market requirement and ISO 27001 already is in some markets. To combine the work might be the best way forward!

We help identify all applicable requirements!

quality planning

How do you plan for the quality system, Is it existing that needs to be improved, Do you need to develop one or have just got stuck in finding solutions to get effective. In the required quality plan for the company you can address many of these issues.

Who do the internal audits. Sometimes an external source find new issues

We help you in all aspects of Quality systems!

Projects

What support is needed in a development project from a Qaulity perspective. We often help companies to be their Quality representative in projects, both to support the project but quite often also train the organization on what is required when it comes to quality compliance. Some of the bigger companies that are our customers use us as second thought advisers for a proposed quality planing. Typical the project also includes the Quality project planning on how to make sure you have your Design History File in place.

We help you securing compliance in your projects?

audit

We are helping many companies to do Due Diligence both in M&A but also when its time to get more money from investors. Internal audits and supplier audits are of coarse another key are we can help and provide you with insights from our experience that are based on hundreds of companies during many years!

Moc audits before Notified body or FDA visits are other popular activities we do! Getting ready for an inspections is extremely important to not get into problems with authorities! Once you are in trouble it is hard to get out of it

We’re Here To Help Your Business

Through Creativity, Integrity & Innovation

LET'S GET STARTED!