Admissions Consulting (Regulatory Affairs)

Product adaptations to changed regulatory requirements

Our experienced consultants ensure the conformity of your products:

  • Preparation of gap analyses for changes in the content of the regulations
  • Evaluation of your product with regard to the results of the gap analysis
  • Listing of the product adjustments to be made
  • Management of the product changes
  • Adaptation of the technical documentation to Annex II of the MDR, STED according to IMDRF or other formats
  • Organization and coaching of any external approval tests that may be required

Creation and maintenance of technical documentation

We help you to achieve and maintain product conformity:

  • Joint creation of a checklist for the required documentation
  • Gap analysis of existing documents/records
  • Creation of a list of work to be done regarding documentation and necessary tests (internal/external)
  • Creation/adjustment of documentation taking into account time-logical aspects
  • Organization/supervision of necessary tests (internal/external)
  • Biological evaluation of the product based on the risk-based approach of EN ISO 10993-1
  • Review and approval of the technical documentation by the customer

European and international approval of medical devices

We support you in gaining access to the European single market and international markets:

  • Checking the technical documentation against the requirements of the Medical Device Directive as well as the corresponding target countries.
  • Research of possibly required comparative products and determination of the approval strategy – Preparation of required documents and records
  • Organization of translations of documents/records into the target language
  • Organization/supervision of necessary tests (internal/external)
  • Extending the QM system to include the requirements of the target countries, e.g. 21 CFR 820 – Quality System Regulation, CMDCAS etc.
  • Support with the submission of the registration documentation
  • Coaching/assumption of the communication with the approval authorities
  • Preparation of and coaching during audits/inspections that may be required
  • Support in the elimination of deviations
  • Coaching/assumption of product registration in the respective target countries

FDA – approvals and coaching

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 comparative products (Predicate Devices)
  • Organization/supervision of necessary tests (internal/external), in particular for bench testing – Preparation of additionally required documents
  • Transfer of existing documents into English – Preparation and submission of the required approval file
  • Extension of the QM system to include the requirements of 21 CFR 820 – Quality System Regulation
  • Support in case of queries, provision of additional documents if necessary
  • Preparation for an FDA inspection, e.g. with a mock audit
  • Training of your personnel in optimal behavior during the inspection
  • Support during the FDA inspection
  • Assistance in dealing with warning letters and deviation reports (Form 483)
  • Planning and implementation of corrective measures after the FDA inspection