Medical Device Regulatory Submissions
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 regulatory submissions & applications and the impact of delays and lost revenue streams due to incomplete, erroneous, or non-compliant data.
We cannot change the current uncertain EC-UK environment with significant depletion of resources in EU27 and UK Notified Bodies; we have advised and successfully transitioned to other Notified Bodies.
We can assist you in what to submit to whom, to meet the more challenging and changing EC and other national regulations and standards.
With our expertise and practice we will, (preferably pre-submission), establish the current status of your Technical Documentation, establish clear plans and routes, prepare / collate the objective evidence of compliance with relevant Regulations / Standards and complete the appropriate submissions to save time and cost.
We support you throughout the application, submission and review process and as appropriate liaise with the Notified Body or other regulatory authority on your behalf, assist in the definition of controls for Launch / Distribution and manage your change notifications.
We have successfully prepared & submitted 4000+ medical device applications for clearance in countries such as:
- Saudi Arabia
- South Korea
Meet your goals on time.