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!
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.
GO
✔️ QMS Structure Compliant*
✔️ Kick-off Meeting
Document Implementation: You1, 2
Length of the Plan: One-off
eQMS System (see here): Optional
GROW
✔️ QMS Structure Compliant*
✔️ Kick-off Meeting
Document Implementation:
Collaboration3
Length of the Plan: 6 months
eQMS System (see here): Optional
PRO
✔️ QMS Structure Compliant*
✔️ Kick-off Meeting
Document Implementation: Collaboration4
Length of the Plan: 12 months
eQMS System (see here): Optional
* Please ask for a list of all the documents included in this QMS Structure that are compliant with your required guidelines (e.g. ISO 13485, GxP).
1 Cross reference matrix provided, we can offer support on an hourly rate basis.
2 Additional cost for support per hour is CHF 225.
3 We help you implement 60% of the documents provided with 2 revisions. Suggested start-up team member available for approx. 8h/month.
4 We help you implement 100% of the documents provided with 2 revisions. Suggested start-up team member available for approx. 5h/month.
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.
Choose from our QMS add-ons to build the most suitable package for your requirements. From Mock-audit / Self-inspection to QMS compliant documentation and maintenance packages, our add-ons offer the flexibility you need to manage your QMS.
1 mock-audit
1 SOP and if required up to a maximum of 2 associated forms and templates.
3 SOPs and if required up to a maximum of 6 associated forms and templates.
5 SOPs and if required up to a maximum of 10 associated forms and templates.
Included (max of 2 hours of support per month):
Included (max of 10 hours of support):
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.
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.
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.
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: