With our experience within the medical device industry and contact to Notified Bodies, we are very well placed to provide advice that works both for you business and is also compliant with the regulators.

We pride ourselves in knowing what is expected from regulators such as Competent Authorities and Notified Bodies, but more importantly how to make that work within your company in the most efficient way.

We can provide support with:

• Remediating audit findings
• Device development and CE marking
• QMS requirements
• Technical Documentation
• Risk Management
• Clinical Requirements
• Standards compliance
• Verification and Validation
• Supplier Management
• Product registration
• Recalls and Adverse Event management
• Product design

Our Medical Device RA & QA team consists of specialists with a high level of expertise within Regulatory Affairs and Quality Assurance of Medical Devices. The team of consultants can assist your company with defining and implementing the regulatory strategy on how to market new or innovative medical devices – from idea to marketing.

We have in-depth experience with:

• Successful development of Medical Devices.
• Timely product registration in EU (CE marking), US (IDE, PMA, 510(k)), Asia, etc.
• Writing clinical evaluations / medical writing.
• Writing technical files, design history files, and product submissions incl design dossiers.
• Vigilance processes for Medical Devices including reporting of adverse events to relevant authorities and Market Corrective Actions (Recalls).
• Defining and implementing Quality Management System procedures required to market Your Medical Device.