Quality made easy
A Quality Management System is a living organism in your startup. Consequently, it will evolve and improve as your startup grows. At HEMEX, we can help you on each step of your QMS cycle, streamlining it to your needs, and making it easier for you to maintain.
Certified Lead Auditors
HEMEX’s certified lead auditors (GMP & ISO Standard) set the standard for excellence and will support you every step of the way.
Degree of excellence
Where quality and swift results are a possibility. HEMEX’s delivers to the highest standards of quality.
Prevent non-compliance
We will work together to demonstrate your company’s core internal skills and knowledge in your next audit.
Optimizing Effectiveness
Either if you want to become a pro at quality management or prefer to hand it over to us, our services are tailored specifically to meet your needs and reduce expenses.
“Our quality assurance team establishes and maintains consistent and reliable standard operating procedures leading to compliant quality practices and efficient processes. We are ISO certified and will ensure you are, too!”
Get smoothly certified
Whether regarding the changes established by the European Union with the new Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR), or GxP compliance guidelines, we have the right know-how in-house to get your product certified and move your business forward.
HEMEX is ISO 9001:2015 and ISO 13485:2016 Quality Management System certified.
Pick your solution
Quality is key for product development success and should be at the forefront of what your startup stands for. We offer tailored, flexible, and supportive packages to help you ensure the highest international quality!
MedTech/IVD
Grow – early stage QMS
Support in understanding and partially establishing/documenting ISO 13485 compliant processes relating to sections such as Quality manual, Document control, Quality policy, Resource management
- SOP templates
- Online kick-off meeting
- 6 months of support
- eQMS software solutions
Pro – advanced QMS
Support establishing an ISO 13485 compliant QMS/eQMS. Full support in identifying processes and documenting them according to procedural requirements (e.g. development, production, supplier control, CAPA, market monitoring, documents control, management review, etc.)
- SOP templates
- Online kick-off meeting
- Up to 2 years of support
- In combination with our Regulatory Affairs services
- Preparation of ISO 13485 compliant QMS documents prepared
- eQMS software solutions
Pharma/Biotech
Support in understanding and establishing your QMS/eQMS to improve your GxP compliance and conduct submissions to Swissmedic, FDA, EMA, BfArM, MHRA, and other regulatory bodies. Full support in identifying and exploring your organization’s preparedness to maintain regulatory compliance and efficient processes in your QMS.
- SOP templates
- Online kick-off meeting
- Preparation of GxP compliant QMS documents prepared
- eQMS software solutions
“The sole reason for HEMEX is to make life less difficult for you. Not only do we think differently about your project, but we also feel differently. With the HEMEX team by your side, quality will be the cornerstone of your startup’s success.”
Add-ons
We can organize a training session or a workshop about Quality Management that is cost-effective, result-oriented, and adapted to your learning interests. HEMEX trainings can help you meet compliance requirements and improve your performance. All our trainings are facilitated by experts with experience in quality management systems.
To prevent risks and fees, we conduct an internal assessment of your quality management system based on the principles of a formal audit. The mock audit takes one day and is conducted fully remotely.
We provide minor updates to SOPs and associated documents and ensure that employee training is accurate and up to date without committing long-term.
We provide major updates to SOPs and associated documents and ensure that employee training is accurate and up to date without committing long-term. In addition, we ensure that documents are ready for inspection.
