As part of your Regulatory Strategy, we provide the expertise to assist you prepare your medical device regulatory submissions and identify the most effective route to gain market clearance in your chosen country.

We understand the frustration, delays and costs associated with all  medical device applications, regulatory submissions & registrations and the impact of delays and lost revenue streams due to incomplete, erroneous, or non-compliant data.

We cannot change the current EU and UK environment with significant depletion of resources in EU27 Notified Bodies and shortage of UK Approved Bodies; we have advised and successfully transitioned to EU Notified Bodies and UK Approved Bodies.

We can assist you in what to  submit to whom, to meet the more challenging and changing EU, UK, other national regulations and standards.

With our expertise and practice we will, (preferably pre-submission), review the current status of your Technical Documentation, establish clear plans and routes, prepare / collate the objective evidence of compliance with relevant National Regulations / Standards and complete the appropriate submissions to save time and cost.

We support you throughout the application, submission, review and registration processes and as appropriate liaise with your the EU Notified Body, UK Approved Body or other national regulatory authority on your behalf, assist in the definition of controls for Launch / Distribution and manage your change notifications.