+46(0) 70 58 60 200 info@medqtech.com Follow us

Medical Device
Regulatory
Compliance
Consultancy &
Services

Working with medical device companies to accelerate their regulatory compliance journey

 
 

Comply
Effectively
with


MDR
2017/745


IVDR
2017/746


QSR
(FDA)


CE-marking process

Your trusted partner specialising in MDR, IVDR and QSR regulatory strategy and compliance

 

We are an effective team extension for medical device companies looking to ensure they can quickly enable their organisations to meet regulatory requirements. With correct classification and known conformity route we help organizations meet and exceed their business goals.

We lead with regulatory strategy, ensuring business value, utilising our experience, knowledge, and eye for detail to ensure resources are utilised to deliver results.

Medical device regulatory compliance
Medical device regulatory compliance

CE marking process

Medical device regulatory compliance

Regulatory applications & registrations (EU/US)

Medical device regulatory compliance

Classification of medical devices

Medical device regulatory compliance

Gap analysis

Medical device regulatory compliance

Regulatory strategy

Medical device regulatory compliance

Your Person Responsible for Regulatory Compliance (PRRC)

Medical device regulatory compliance strategy packages

 

Our regulatory compliance strategy service package includes a proven step by step process to set your regulatory compliance platform. In our service you will have access to regulatory experts with extensive experience in conducting regulatory strategies for medical device companies.

The structured approach will help you design and execute your market approval so that you can be confident that your innovation transfers to desired markets in a compliant way.

Regulatory strategy will vary depending on the regional directives and regulations you are aiming to comply to. We have significant experience in achieving regulatory compliance for MDR (MDD) and IVDR (IVDD) within the EU, and QSR within the US. We also support organizations to meet regulations where their medical device has intended use, such as Canada and Australia.

Ongoing strategic medical device consultancy

 

We are passionate about the medical device industry, and where we see an opportunity to help your business we will highlight it. In a role that considers many elements of a medical device organization and product solution, we have the luxury of a broad perspective with experienced heads.

We work with companies on specific assignments, with ongoing advisory support or in full projects. Often we start work with a client on a project and it turns into an ongoing
partnership – focusing on business value.

Medical device regulatory compliance

“MedQtech joined our organisation to help us strategize our regulatory compliance. They guided us on regulations, our QMS, and have worked with our management team and design and development team to enhance business processes. They are a regular part of our team, enhancing our industry knowledge”

 

Medical device company

Our Valued Clients