Expand, embrace, and ensure quality

QUALITY is key for product development success and should be at the forefront of what your company stands for. We offer flexible and supportive packages to help you find the optimal solution. GO now, GROW alongside us, and manage your QMS like a PRO from today, to ensure great QUALITY!

Get your free consultation

Our QMS Packages

We offer three different packages to help you create and implement your own Quality Management System for pharmaceuticals or medical devices/in vitro diagnostics, compliant with EU, US and CH guidelines and regulations.

Features

QMS Structure Compliant

Document implementation

Technical Documentation*

Mock Audit / Self Inspection

Hours of Initiation Training

Length of Plan

CHF 4’999

(one off)

eQMS System (see here)

GO

QMS Structure Compliant: ✔️

Document implementation: You1

Technical Documentation*: Hourly rate2

Mock Audit / Self Inspection: Optional5

Hours of Initiation Training: 4

Length of Plan: One-off

CHF 4’999

(one off)

eQMS System (see below): Optional

GROW

QMS Structure Compliant: ✔️

Document implementation: Collaboration

Technical Documentation*: 150 hours3

Mock Audit / Self Inspection: 1 Mock Audit

Hours of Initiation Training: 8

Length of Plan: 12 months

CHF 1’999

(per month)

eQMS System (see below): Optional

PRO

QMS Structure Compliant: ✔️

Document implementation: Collaboration

Technical Documentation*: 700 hours4

Mock audit / Self Inspection: 2 Mock Audits

Hours of Initiation Training: 16

Length of Plan: 24 months

CHF 3’999

(per month)

eQMS System (see below): Optional

Detailed Information

1 Cross reference matrix provided, we can offer support on an hourly rate basis.

2 Additional cost per hour is CHF 200.

3 Additional cost per hour is CHF 175.

4 Additional cost per hour is CHF 150.

5 A mock audit of 8 hours would cost CHF 1,600.

* We will send you a monthly report of the hours you have used to ensure you make the most of them. Once the contract time period has ended, the unused hours cannot be carried forward.

 

To upgrade from one package to another, any costs already paid for the previous QMS package will be carried forward to allow you to upgrade to a package which offers you more support. 

Additional Support

Documentation to comply with additional standards (ISO and other)

GDPR support (24/7/365 EU presence), DPO services

Process Management, Verification & Validation, Qualification

To prepare a product for manufacturing and sales, processes need to be established, implemented, and maintained via a risk-based approach. These processes allow for testing of the product against the specifications during verification testing and against user requirements during validation. Our team takes care of all these steps and can support in a lean and effective way.

Powered by

Process Management

Risk-based process management generates lean, risk-aware processes for sustainable procedures and easy integration into existing process landscapes. We offer a modular and flexible approach to process management.

Process management includes maintenance and effectiveness measurement. The latter is underpinned by a QMS. HEMEX can support you in implementing measures and novel forms of analytics to manage implemented processes.

Get your free consultation

Verification & Validation

We support you in the Verification of your product. Whether in writing the plans, executing the testing, analyzing the results or reporting on the outcome, our team are experts in mechanical and dimensional testing. In case you are short on manpower, our team can support you in the management, organization and hands-on support during verification testing of your device.

Validation testing against user requirements usually comes in the form of a summative usability study. We can support you in the organization, planning, and reporting on the results and outcomes. In the case that you are planning on conducting the validation testing externally, we can support you in the communication and organization of external usability testing organizations and manage sample request, re-supplies, and study timing.

Get your free consultation

Qualification

Measuring equipment and processes need to be installed and checked against fixed parameters. Our team can support you with the organization, management, planning, execution and reporting of all qualification work needed to allow your newly manufactured products manufactured to reach the market.

Our support can be on-site, remote or at the Contract Manufacturing Organization (CMO), depending on your demands and supply chain.

We provide services in the following:

  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
Get your free consultation