Quality and Regulatory
A Culture Dedicated to Quality:
Customer satisfaction and compliance with all relevant legal, normative and regulatory requirements are at the forefront of Deltex Medical’s vision on Quality.
We have a comprehensive and certified Quality Management System and each employee wholeheartedly adopts our Quality Policy
Compliance with Regulations
Deltex Medical have implemented and maintain a Quality Management System in compliance with the Medical Device Single Audit Program (MDSAP) requirements, MDR 2017/745/EU as well as other global Quality system requirements as applicable.
Deltex Medical Business Social Responsibility & Compliance
Deltex is dedicated to operating in accordance with the highest ethical behaviour in the communities in which we live and operate, internationally. Principal facilities are owned and operated by Deltex, where employees’ working conditions are maintained in accordance with international and local laws. The company Code of Conduct is clearly communicated to and understood by all management and employees. Deltex stands firmly in our resolve to do our best for our employees, customers and suppliers each and every day.
Ethical Treatment of All
Our employees and suppliers are the foundation for the continued success of our business.
- Working conditions are safe and hygienic.
- Equipment is safe and well-maintained.
- Employees are provided personal protective equipment (PPE) as necessary and trained in the safe handling of equipment and consumables.
- Regular health and safety training is conducted.
- No harsh or inhumane treatment is allowed.
- Employment is fair and totally at-will.
- Employees have the freedom of association and the right to collective bargaining.
- Child labour is strictly prohibited.
- Discrimination, in any form, is prohibited.
- Fair living wages and fees for products and/or services are paid.
Anti-Bribery & Corruption
It is Deltex’s policy to conduct all business in an honest and ethical manner. We take a zero-tolerance approach to bribery and corruption and are committed to acting professionally, fairly and with integrity in all our business dealings and relationships. We operate and enforce systems to counter bribery. We will uphold all laws relevant to countering bribery and corruption in all the jurisdictions in which we operate. We remain bound by local and national laws.
Sustainability
Deltex Medical is committed to making a positive impact on the environment. We apply green thinking throughout the company, dedicating ourselves to maintaining standards within our supply chain, manufacturing, and administrative operations. Our goal is to do our part in improving environmental sustainability for our customers, suppliers and employees.
Deltex’s sustainability objectives include:
- Measurably reducing the amount of waste produced in our departments.
- Investigating sustainable products and services designed to improve energy consumption and production expenditure (materials, packing, and shipping).
Conflict Materials and Minerals Usage
Deltex is committed to the ethical sourcing of components and materials used in our products. Deltex complies with the requirements of the SEC’s Conflict Minerals rule and expects our suppliers to do the same. Deltex does not directly purchase raw metal ores that may be used in the manufacture of products from smelters or mines. In support of Deltex’s policy on conflict minerals, suppliers are expected to supply materials to Deltex that are “DRC (Democratic Republic of Congo) Conflict-Free”. Suppliers are expected to adopt policies and management systems with respect to conflict minerals and to require their suppliers to adopt similar policies and systems.
FAQ
Is your QMS certified to the relevant regulations?
Yes, this is our MDSAP Certificate.
Have you submitted pre-market notifications to the FDA (510k)?
Yes.
Do you have an equal opportunities policy?
Yes, this is our Equal Opportunities Policy
Are products CE marked?
Yes.
How do I get a copy of the IFU?
All products are accompanied by a copy of the relevant IFU. If another copy is required, please contact Customer Services or download an electronic version from here.
Can I get a copy of the Declaration of Conformity to the MDR?
Yes, please contact our Quality and Regulatory Manager using the information below.
What is the warranty period for Monitors?
Deltex Medical guarantees its products in respect of faults in materials and manufacture for a period of 12 months from delivery under normal conditions of use.
Who should I contact if I have a complaint?
You may contact your nearest Deltex Medical Field Staff member, or you may contact Customer Services.
How long will it take to resolve my complaint?
We aim to resolve all customer complaints within 30 days.
Do you have a Code of Conduct?
Yes.
Does the product contain silicone?
No.
Do you comply with ROHS/REACH Directives?
Yes.
Are there any phthalates, latex or bisphenyl A (BPA) present in the device?
No.
My probe is past its expiry date, what should I do?
Do NOT under any circumstances use an expired probe.
Have you conducted a clinical evaluation for the products you manufacture?
Yes.
Do you adhere to the Ethical Trading and Slavery Policy 2015?
Yes.
Contact
For any enquiries relating to Quality and/or Regulatory, please contact customer services.
