Quality and compliance
We have strong global and local quality standards in healthcare and pharma
Our commitment to quality is about more than delivering your pharmaceutical products and medical devices to their required industry standards and regulations
We take the quality of our own internal business operations just as seriously.
Our approach to excellence as standard
At SteriPack, we strive for excellence in everything we do, through committing to these principles:
- Everyone within the organization knows the importance of meeting customer needs, as well as statutory, legal and regulatory requirements.
- We manufacture safe and effective products that perform as intended while being used by healthcare professionals or end users.
- We place high priority on offering value through innovation, products and services. Not only to our customers’ businesses but to the customers and communities they serve.
- We foster a culture of teamwork and quality throughout every team.
- We develop good working relationships with our suppliers and collaborate with them to enhance service.
- We undertake continuous improvement to maintain the effectiveness of our Quality Management Systems (QMS) to meet our customers’ expectations and objectives.
Certified to design and manufacture your healthcare innovation
We offer design and product development, design for manufacture, contract manufacturing and contract packing capabilities to the pharmaceutical and medical device industry. We approach every project with rigorous quality management systems and corresponding compliance, backed by relevant certifications.
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ISO 13485:2016 Certificate
USA - Morristown, NJDownload -
Medical Device Regulation 2017/745 Certificate – Collecting swabs
USA - Lakeland, FLDownload -
EN ISO 13485:2016 Certificate
USA - Lakeland, FLDownload -
Japan Registration Certificate of Foreign Medical Device Manufacturer
USA - Lakeland, FLDownload -
ISO 13485:2016 Certificate
UK - BristolDownload -
ISO 9001:2015 Certificate
UK - BristolDownload -
ISO 13485:2016 under MDSAP
Poland - WroclawDownload -
Pharmaceutical Manufacturing Authorisation
Poland - WroclawDownload -
Japan Registration Certificate of Foreign Medical Device Manufacturer
Poland - WroclawDownload -
PN-EN ISO/IEC 17025:2018 Accreditation
Poland - WroclawDownload -
Certificate of GMP Compliance
Poland - WroclawDownload -
EN ISO 13485:2016 + A112021
Poland - WroclawDownload -
EC Certificate under MDD
Poland - WroclawDownload -
ISO 13485:2016 Certificate
Malaysia - Klang, SelangorDownload -
Pharmaceutical Manufacturing Licence
Malaysia - Klang, SelangorDownload
Taking customer confidentiality and security seriously
At SteriPack, data security and compliance are of paramount importance. By maintaining and implementing various policies and protective measures, we ensure the highest standards of data security and compliance. This means we safeguard our customers and employees, and earn your trust as a global provider of contract design and manufacturing services.
We can help you take high quality steps forward
We’re here to help you make quality products, that bring more patients quality care. Get in touch to discover how we can tailor our manufacturing solutions to your goals.