Consultant, ISO 13485, FDA QSR, Medical devices, Quality Management Systems

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acrapack regulatory consulting how we can help

We have the experience and expertise when you need them to talk about your regulatory needs.

We can help unravel your registration compliance and quality problems, by understanding your product to market goals and to help bring your dream to life.

Providing you with regulatory consulting

Solutions to your compliance challenges

Experience to complete your registration projects within agreed time frames and costs

The right advice to ensure your healthcare products are marketed in compliance to international regulations

Post market regulatory support to ensure the requirements for each of your markets is maintained to the meet regulatory compliance.

Practical implementation methods for developing and adjusting your company’s Quality Management System in accordance with ISO13485 and the FDA's 21 QSR 820 to meet your business requirements

Support for your company to ensure compliance to the international requirements of US FDA Quality System (QS) Regulation / Medical Device Good Manufacturing Practices (GMP); ISO 9001: 2008 and ISO 13485: 2003 Medical devices – Quality management systems – Requirements for regulatory purposes

Regulatory project management for medical device
"Anne looked after a tricky transition registration for one of our medical devices. She was happy to resolve each hurdle and kept me informed all the way. It was a pleasure to have someone take ownership and see the project through to the end, especially since I was busy with other projects."
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Let Acrapack assist you with your quality system development or regulatory activities

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