Medical Devices

Are regulatory requirements causing headaches? Are the European Commission’s two new draft regulations causing implementation challenges? Is there not enough time for building and developing a quality management system?

Quality manager

  • Providing a professional and experienced quality manager at your service
  • Building a quality system for you that fulfills the requirements of the authorities (ISO 9001, ISO 13 485, ISO 14 971)
  • Maintaining and develop your quality management system
  • Audits
  • Creating and update your standard operating procedures and process descriptions
  • Training your staff

Importing and the manufacturer’s responsibilities and obligations

  • Sorting out the regulatory requirements, and prepare the required documents
  • Helping with the application of the FDA’s GMP-requirements and the European manufacturing requirements

Safety and incidents

  • Setting up an incident reporting system (MEDDEV 2.12 / 1, Medical devices vigilance system)
  • Taking care of the trend monitoring and periodic summary reports associated with safety and hazardous situations
  • Handling incident reporting, and help with the planning of corrective measures and the design of the safety data sheet
  • Acting as a contact link between the authorities, manufacturer and importer

Technical documentation and notifications required by the authorities

  • Taking care of official contacts and the necessary authority consultation
  • Preparing the necessary declarations and write technical documentation
  • Helping with clinical assessment and drafting of clinical documentation
  • Helping with classification and CE marking questions
Anni Svala
+358 44 369 8522