SinQS

Simplicity in Quality Systems

What SinQS offers

SinQS helps:

Medical Device Start-up companies,
Medical Device Manufactures, and
Related Suppliers.

To enable:

First time right market authorization,
Full risk based QMS, and
Maintaining compliance.

And provides services:

Throughout the lifecycle of your medical device,
For and within your quality management system,
To ensure you meet relevant (regulatory) requirements,
As Person Responsible for Regulatory Compliance - PRRC, and
As EU Authorized Representative
As Mentor to help QA and RA professionals, including consultants

What you might be looking for

SHOP:

Time is a limited resource, you can only use it once.

Therefore the SHOP has been established to support you in creating your QMS, Technical documentation for your device(s), or Auditing documentation without hiring consultancy services if you desire to create these on your own or with limited help.

SinQS provides in the SHOP a framework of documents and templates that require at least customization in order to fit your organizations needs.

Services can be provided if help is needed regarding this customization.

Go to SHOP

Services:

Knowledge and experience comes with time.

Therefore help and insourcing of knowledge and experience may assist your organization with the QMS and regulatory challenges present and ahead.

SinQS provides the knowledge and experience regarding QMS, Technical Documentation, Auditing, or Regulatory Compliance.

In practice often the knowledge and experience is present but time itself is not sufficient to make the required changes. Mostly because daily and operational work requires to continue. In these situations it might be helpfull to insource SinQS as well. This may help you in achieving your objectives in a timely manner as agreed with your management.

Go to Services