Medical Device Quality Management System – Arrotek

Medical Device Regulation Experts

Establishing an effective medical device quality management system at the beginning of the design process is essential to efficiently and effectively obtain regulatory approval for your new product idea. You need a team that understands the medical device regulation landscape in the territories that are most important for the success of your product.

At Arrotek, we have the knowledge, experience, and expertise you need.

13485 Design Company – Helping You Obtain EU and FDA Certification

We value and understand the importance of complete dependability both in terms of the service we provide and the product we help you develop.

As a result, everything we do at Arrotek is carried out in accordance with our ISO 13485:2016 & EN ISO 13485:2016 accredited Quality Management System for medical devices. This certification relates to:

“Contract design, development, manufacture and packaging of sterile and non-sterile plastic-based medical devices: needles, sheaths, catheters, introducers, handles, dilators, leads and delivery systems to customer specifications.”

You can view our certification here.

To find out more about our medical device Quality Management System, or if you have a query, please get in touch.

Obtaining Regulatory Approval for Your New Medical Device

We are FDA registered and audited and currently supply finished sterile products to the US market. We are also European medical device regulation experts with extensive knowledge of EU MDR (the EU’s medical device regulations). In addition, we have experience of other regulatory requirements elsewhere in the world.

This means we can guide you through CE marking, FDA submission, and other regulatory requirements you have.

Medical Device Quality Assurance and Regulatory Services

At Arrotek, we provide a full range of quality and regulatory services with the objective of helping you bring your product to a market-ready state as quickly and effectively as possible.

In other words, we offer the expertise you need in medical equipment design, manufacturing, quality, and regulatory approval.

Our services include:

  • Process Validations
  • Sterilisation Validation
  • Age testing for shelf life
  • Transportation Testing
  • Bench testing of transport and aging units
  • Clinical language verification for instructions for use
  • Testing to ISO standards
  • Label design
  • File compilation and submissions for regulatory approvals.

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Regulatory Evaluation of Your New Medical Device

A good first step you can take if you have an idea for a new medical device product is to get our expert team to conduct a regulatory evaluation. You can do this in complete confidence as confidentially is guaranteed, plus you retain 100 percent ownership of all intellectual property.

To find out more about getting a regulatory evaluation, contact us now at sales@arrotek.com, or phone us at +353 71 91 15111.

Quality and Regulatory Services