Regulatory Affairs

Our experienced consultants ensure the conformity of your products:

  • Determination of current approval requirements and legislation for your target countries
  • Preparation of gap analyses on changes to the content of the legislation,
  • Evaluation of your product in light of the gap analysis results,
  • List of product adjustments to be made,
  • Management of product changes,
  • Adaptation of the technical documentation to Annex II of the MDR, STED according to IMDRF or other formats and
  • Organization and coaching of any required external approval examinations.

We help you to achieve and maintain product conformity:

  • Joint creation of a checklist for the required documentation,
  • Gap analysis of the available documents / records,
  • Creation of a list of work to be carried out regarding documentation and necessary inspections (internal / external),
  • Creation / adaptation of the documentation taking into account time-logical aspects,
  • Organization / monitoring of necessary audits (internal / external),
  • Biological assessment for components and medical devices with patient contact based on the risk-based approach of EN ISO 10993-1,
  • Biological assessment for components and medical devices with airway contact based on the risk-based approach of EN ISO 18562-1 and
  • Review and approval of the technical documentation by the customer.

We support you in accessing the European Single Market and international markets by means of:

  • Development of EU and FDA approval strategies
  • Checking the technical documentation against the requirements of the Medical Devices Regulation and the relevant target countries,
  • Research for any required reference products and determination of the approval strategy – Preparation of required documents and records,
  • Support for regulatory-compliant labeling of your products,
  • Organization of translation of documents / records into the target language,
  • Support in the planning, implementation and documentation of verification and validation activities,
  • Support with planning, implementing and documenting reprocessing and sterilization validations,
  • Organization/supervision of necessary audits (internal / external),
  • Expansion of the QM system to include the requirements of the target countries, e.g. 21 CFR 820 – Quality System Regulation, MDSAP, etc.,
  • Support with the submission of approval documentation,
  • Coaching / taking over communication with the competent authorities,
  • Preparation of and coaching for any necessary audits / inspections
  • Support in the elimination of deviations and
  • Coaching / taking over product registration in the respective target countries.

With our help, your products and processes become FDA-compliant:

  • Determination of the approval strategy for
    • Pre-Market Approval (PMA),
    • Pre-Market Notification (510[k]),
    • Investigational Device Exemption (IDE),
    • Humanitarian Device Exemption (HDE),
  • Search for reference products (predicate devices),
  • Organization/supervision of necessary tests (internal/external), in particular for bench testing – Preparation of additionally required documents,
  • Translation of existing documents into English – Preparation and submission of the required approval file,
  • Expansion of the QM system to include the requirements of 21 CFR 820 – Quality System Regulation,
  • Support with queries, provision of further documents, if necessary,
  • Preparation for an FDA inspection, e.g. performing a mock audit,
  • Training your staff in optimal inspection behavior,
  • Accompanying the FDA inspection,
  • Help with handling warning letters and deviation reports (Form 483) and
  • Planning and implementation of corrective actions after the FDA inspection.