Quality & Regulatory

Quality & Regulatory

Medical Device Quality Management System

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. 

Medical Device Regulation Experts

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.

You can view our certifications here:

BSI Certificate Arrotek Medical MD96205.

SGS Certificate NeedleTech Products US18/81841262

Medical device regulators place a significant emphasis on quality in the design and development and production control phases. At Arrotek, we have the expertise and experience required to meet quality and regulatory requirements. Our high-quality standards will help your company improve patient outcomes, reduce risk, and increase the commercial viability of your new medical device.

We will work closely and transparently with you to design and manufacture a high-quality product in a GMP-controlled facility in accordance with regulatory, statutory, and customer requirements.

Obtaining Regulatory Approval for Your New Medical Device

At Arrotek, we have the US, EU MDR, and OUS regulatory expertise to help you stay compliant with regulations in the markets you target.

We can also assist you with CE marking, FDA submissions, and other regulatory requirements.

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

Obtaining Regulatory Approval for Your New Medical Device

Medical Device Regulatory and Quality Services

At Arrotek, we provide a full range of quality and regulatory services to help 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 compliance to streamline your approval, product qualification, and manufacturing processes.

Our services include:

  • 510(k) & MDR applications
  • Design History File compilation and reviews      
  • Process validations – IQ, OQ, & PQ      
  • Process hazard analysis      
  • Design hazard analysis       
  • Full Risk Management Plan and report       
  • Preparation for manufacture                         
  • Sterilisation validation and management
  • Label design
  • Packaging design
  • FDA Pre-sub meeting
  • Biocompatability rational
  • Technical file authoring support
Medical Device Regulatory and Quality Services

Medical Device Testing

We offer extensive medical device testing services at Arrotek. We have equipment to complete a range of different tests in addition to an experienced and highly knowledgeable team.

Our testing services include:

  • Testing to ISO standards
  • Usability testing
  • Age testing for shelf life
  • Dropship testing

To speak to a member of our team about your requirements, please contact us today on +353 (0)71 91 15111. You can also email us on [email protected].

Regulatory Evaluation of Your New Medical Device

Do you have a concept or a prototype of a new medical device and want to know the next steps? Let our experts perform a confidential regulatory evaluation of your device. This initial evaluation will help you move forward with your project while leaving you with 100 percent ownership of all intellectual property.

To find out more about getting a regulatory evaluation, contact us now at [email protected], or phone us at +353 71 91 15111.

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