Regulatory

The healthcare industry is governed by standards and regulations defining the technical requirements for medical packaging materials.
With sales in more than 70 countries and a Regulatory Affairs department in place to track all changes to regulations, we strive to maintain the best of compliance for all the products we bring to market.
 

 

Quality Control, Regulatory Affairs
and Risk Management 

  • ISO 13485: 2016 quality system
  • Packaging materials and Preformed Sterile Barrier System in compliance with ISO 11607-1 and EN ISO 11607-1 requirements
  • Membership to Sterile Barrier Association, a member to Eucomed
  • Dedicated resources for risk management & regulatory affairs

Our products are tested for bioburden, cytotoxicity, sterilization compatibility, aging and much more. 

 

Industrial Performance

  1. We dedicate our machines to healthcare substrates only, for optimal process stability and minimal risk of cross- contamination.
  2. We run our equipment with a key focus on continuity of production and consistency of products.
  3. More than 20 million € have been spent over the last 10 years to develop our tooling and support continuous improvement in our manufacturing processes.

 

Product Performance

Safety and consistency are two key assets of our products

  1. We are the market reference for the design of tailor-made solutions to customer-driven technical requirements.
  2. We take into account our client's process conditions to deliver products that will help them in improving performance, design or value.
  3. Our current product portfolio is the result of years of learning and partnering with leading companies of the medical device and pouch making industry, and bringing successful solutions to their packaging needs.

 

 

Accreditations of Manufacturing Sites

Palalda

Palalda plant:

  • ISO 13485 : 2016
  • ISO 50001 : 2011

Brno site:

  • ISO 13485 : 2016
  • ISO 9001 : 2015

Charleston site:

  • FDA 21 CFR 820

Suzhou site:

  • ISO 13485 : 2016