Consultancy Services
The Way We Work

1-Gather  Information

To clarify the requested service details, we ask you to fill a form about your medical device.

2-Share Proposal

The proposal including the scope, terms, responsibilities of the parties and the due date of the project delivery is shared.

3-Sign an NDA & Service Agreement

After the proposal is accepted, NDA and service proposal is shared to secure parties.

4-Kick off Project

The project manager is assigned to the project. A meeting is organized to determine the way of sharing required documents and inform you of the process. 

5-Execute Project 

The draft copies of the prepared documents are shared with your team to ask for their reviews and suggestions.

6-Deliver Project  

Upon getting your consent to draft documents, we share final versions of them.

Why You Should Consult Us?

The reasons why you should prefer AdviQual when you need consultancy and training services on quality, regulations, and processes in medical device production can be listed as follows;

•    AdviQual supports medical device manufacturers for quality and regulatory affairs according to the most updated regulations and standards, such as MDR, EN ISO 13485:2016, EN ISO 14971:2012, ISO/TR 80002-2:2017, ISO 10993-1:2018, EN 62304:2006+A1:2015, etc.

•    No matter which product you manufacture or where you are located in, the outcomes of our services are fully compliant to regulations and standards which increases compliance of your company.

•    We guide your quality team, or review and update your present documents.

•    or together with you, we prepare from scratch all the quality related documents such as Design dossier, Risk management files, Biocompatibility test reports, Clinical evaluation reports (CER), PMS documents, PMCF plans and if needed the whole Technical File of a medical device.

•    We work with many medical device manufacturers from start-ups to global companies in many countries from Germany to Qatar. 

•  Our specialized professionals accomplish dozens of reports, files for a wide variety of medical products. This brings us a huge know-how that is accumulated from past projects.

•    Prompt responses, short delivery times and affordable services are our routine which differentiates AdviQual from others.