Medical Device Manufacturers

 

Our team of experts serves medical device manufacturers by providing comprehensive consulting services for, among other things, global product registration. Our experts all have more than 15 years of experience in the registration, quality and product development of medical devices. We have made hundreds of registrations in over 40 countries. We also provide training related to the requirements for medical devices.


 

MARKET ACCESS

The services provided by Labquality will streamline market access for medical devices.


Regulatory Plan >>
Qualification and Classification of Medical Devices>>
EU MDR & IVDR >>
US Sales Approvals >>
ROW Sales Approvals

QUALITY MANAGEMENT SYSTEMS

Labquality’s experts provide assistance in building and managing quality management systems.


Quality Management System ISO 13485 >>
US FDA 21CFR Title 820 (QSR) >>
QMS Improvement and Gap Analysis >>
Internal and Supplier Audits >>
MDSAP Mock Audits >>

DEVICE REQUIREMENTS

The solid know-how and experience of Labquality’s experts brings clarity to device requirements and regulations.


Technical Documentation
General Safety and Performance Requirements
Clinical Evaluation / Performance Evaluation >>
Risk Management ISO 14971 >>
Usability IEC 62366
Biological Safety ISO 10993 >>
Electrical Safety IEC 60601 >>
Labelling / UDI
Post Market Activities

 


 

Regulatory Essentials in Health Tech -training series

The training series provides an efficient introduction to the regulatory essentials to turn regulatory compliance into a business advantage and to avoid the typical pitfalls of the health tech sector.

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Clinical evaluations and investigations

Clinical investigations are demanding processes, but they are also the most reliable way to produce high-quality information about the operation of a medical device. Labquality provides services and expertise in the planning, preparation, and conduct of clinical investigations.

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IVDR compliance for in-house developed tests

The new In Vitro Diagnostic Medical Device Regulation (IVDR) is applied in phases starting on 26 May 2022 . The IVDR and the national law of each EU Member State also concerns in vitro diagnostics (IVDs) developed in-house by clinical laboratories. 

Read more >>


 

MEDICAL SOFTWARE

Labquality also provides comprehensive support for medical software developers.


Medical Software Requirements
Software Life Cycle IEC 62304
Software Risk Management
Software Validation

EXPERT RESOURCES

Labquality’s experts can work in a variety of expert roles on behalf of your company.


Person Responsible for Regulatory Compliance (PRRC)
Quality Manager
EC Authorized Representative (EAR)

Contact us for more information

 

 

 

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