Our business activities include:

• Adaptation of products to changed regulatory requirements 
• Preparation and maintenance of technical documentation
• European and international approval of medical devices
• FDA approvals and coaching

We are happy to provide you with an individual quotation for other topics of interest to you.

Adaptation of products to changed regulatory requirements

Our experienced consultants ensure the conformity of your products:

• Preparation of gap analyses regarding regulatory content changes
• Evaluation of your product based on the results of the gap analysis
• Listing of product changes for implementation
• Management of product changes
• Adaptation of the technical documentation to Annex II of the MDR, STED following IMDRF or other formats
• Organization and coaching regarding external verification and approval testing that may be required

Preparation and maintenance of technical documentation

We support you in gaining and maintaining product conformity:

• Joint preparation of a checklist for the required documentation
• Gap analysis of the existing documents/records
• Preparation of a list with work to be completed regarding documentation and required tests (internal/external)
• Preparation/adaptation of the documentation under consideration of chronological aspects
• Organizing/accompanying required tests (internal/external)
• Biological evaluation of the product using the risk-based approach according to EN ISO 10993-1
• Review and approval of technical documentation by the customer

European and international approval of medical devices

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

• Review of the technical documentation in the light of the Medical Device Directives requirements and the corresponding destination countries
• Research for possibly required comparable products and establishment of the approval strategy –  preparation of the required documents and records
• Organizing the translation of documents/records into the target language
• Organizing/accompanying required tests (internal/external)
• Expansion of the QM system by the requirements of the destination countries, for example 21 CFR 820 – Quality System Regulation, CMDCAS and so on
• Support for the submission of approval documentation
• Coaching/handling communication with the approval authorities
• Preparation and coaching for possibly required audits/inspections
• Support for the elimination of deviations
• Coaching/handling product registration in the respective destination countries

FDA approvals and coaching

Your products and processes become FDA-compliant with our help:

• Establishing the approval strategy
  • Pre-Market Approval (PMA),
  • Pre-Market Notification (510(k)),
  • Investigational Device Exemption (IDE)
  • Humanitarian Device Exemption (HDE)

• Research for comparable products (predicate devices)
• Organizing/accompanying required testing (internal/external), in particular bench testing – preparation of additional required documents
• Translation of existing documents into English – preparation and submission of the required approval file
• Expansion of the QM system by the requirements of 21 CFR 820 – Quality System Regulation
• Support with further enquiries, submission of additional documents if required
• Preparation for an FDA inspection, for example conducting a mock audit
• Training your personnel regarding optimum conduct during the inspection
• Accompanying the FDA inspection
• Help with handling warning letters and deviation reports (form 483)
• Planning and implementation of corrective actions after the FDA inspection