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Let our regulatory experts guide you to obtain the CE Mark and the FDA’s clearance/approval for your medical device.

Pre-defined, deliverable based fees. No retainer or open-ended hourly fees.

Regulatory Services

Activity FDA CE
  1. Regulatory Strategy
  1. Preliminary opinion letter, or:
  2. Comprehensive regulatory strategy
  1. Preliminary opinion letter, or:
  2. Comprehensive regulatory strategy
  1. Early interaction
  1. Pre-submissions
  2. Requests for information (513(g))
  1. Preliminary communication with a potential Notified Body
  2. Evaluating approach towards product classification and subsequent requirements
  1. Submissions
  1. IDE
  2. 510(k)
  3. De-Novo
  4. PMA
  1. Technical File
  2. Design Dossier

QMS and Risk Management

Activity Deliverables
  1. QMS Part 1
  1. Implementation of relevant parts of your product's Quality Management System (QMS) (e.g., Design Controls and other aspects essential for US and EU pre-study compliance) is a legal requirement in both the US and Europe for devices in medium and higher risk classes prior to starting clinical studies
  2. Even for Class I devices, many manufacturers voluntarily implement a QMS at the design stage to reduce the potential for complaints and recalls once the product is launched
  1. QMS Part 2
  1. For all but the lowest risk devices, the manufacturer will need to implement a QMS. In the US, compliance with the Quality System Regulation (QSR) detailed in 21 CFR 820 is required for the majority of devices - even some Class I devices. In Europe, compliance with one of the QMS annexes (equivalent to EN ISO 13485) of the appropriate medical device Directive is required except for Class I devices
  2. While the clinical study is underway it is the ideal time to turn your management's attention to completing implementation of the selected QMS., expanding it beyond design controls to include such areas as manufacturing, service, CAPA, etc. By the time the investigation is complete, you should have the necessary QMS certification to allow the device launch and subsequent marketing

Clinical Data

Activity Deliverables
  1. Clinical Study Protocol
  1. The protocol for a medical device clinical study must meet the legal requirements in the countries where the investigation will take place. For the US, protocol approval must be obtained from FDA for a 'significant risk' study, via the Investigational Device Exemption (IDE) process. In Europe, the requirements of standard EN ISO 14155 should be met in order to gain a 'presumption of conformity' with the Essential Requirements requiring validation of safety and clinical performance
  1. Clinical Study
  1. Prior to commencing any clinical study, Ethics Committee (EC) (or Institutional Review Board in the US) approval must be obtained. Each EC has its own procedures that must be followed in terms of the documentation required, and these must be met at the first opportunity to avoid delays that could compromise milestone achievements and investment
  2. After the clinical investigation and publication of the final study report, in Europe it is a requirement to develop a Clinical Evaluation Report (CER). This may be based solely on the results of the study, or on a combination of study results and data from the scientific literature. From whatever source the clinical data is derived, the evaluation must follow a "defined and methodologically sound procedure". Even for the US, a well-researched and presented CER can be useful for FDA device clearance or approval

Regulatory and clinical data development experience in the US, Europe, Canada and Asia-Pacific

  • Europe
  • Germany
  • UK
  • rance
  • Italy
  • Spain
  • Netherlands
  • Switzerland
  • Belgium
  • Sweden
  • Austria
  • Denmark
  • North America
  • USA
  • Canada
  • Other
  • Australia
  • Israel

Flat fees, concrete timelines, and support through your entire regulatory and clinical development process