Regulatory Work

Regulatory Work

From start-ups to well-established businesses, we lead medical device regulatory consulting and quality management.

Medical devices are often at the edge of technology. Because of this level of innovation, there are strict guidelines around how a product can be brought to market and stringent standards making sure the devices maintain the utmost quality standards.

Waddell Group provides medical engineering consultant and project management to help navigate regulatory and quality complex systems and standards to make sure your product can make it to market. There are significant regulatory shifts occurring and we have the regulatory specialist – and the staffing partners – you need to stay compliant with MDSAP, MEDDEV, ISO 13485:2016, and MDR. From ISO 13485 gap analysis to MRD gap analysis to medical device compliance consulting we offer expertise and project management to establish systems, keep yours current, or get yours back in compliance!