APS Regulatory Consulting Services will create a global regulatory strategy and plan for timely product approval and registrations for low to high risk product, including:

  • FDA Premarket Notification 510(k)
  • De Novo Submissions
  • Investigational Device Exemption (IDE)
  • Humanitarian device exemption (HDE)
  • Premarket Approval Application (PMA)
  • Technical Documentation (Technical Files/Design Dossiers) under MDR/IVDR for CE Mark
  • Global Product Registration Dossiers
  • US FDA Agent

APS Regulatory Consulting Services can assist in developing a compliant quality system:

  • Design Control and Documentation
  • Risk Management
  • Design Verification and Validation
  • Software Verification and Validation
  • Process Validation
  • Create an effective, sustainable compliance strategy
  • Support compliance with EU Medical Device Directives and transition to EU Medical Device Regulations to obtain CE Mark for your medical device
  • Satisfy FDA QMS requirements, ISO 13485 requirements, Canadian Medical Device Regulations (CMDR), and other global requirements including MDSAP

Transition to the new EU Medical Device Regulation (MDR) and IVD Regulation (IVDR):

The Medical Device Regulation (MDR) 2017/745/EU and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746/EU were published in May 2017, after five years of development. They are the first major changes to the EU medical device regulatory environment in more than 20 years and will replace the three existing medical device directives, Directive 90/385/EEC regarding active implantable medical devices (AIMD), Directive 93/42/EEC regarding medical devices (MDD) and Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD). The new EU regulations are much tougher than the directives they are replacing, and they will transform the way you do business in the EU.

Significant EU MDR and IVDR Dates:

  • MDR and IVDR Publication Date: May 5, 2017
  • MDR and IVDR Entry-Into-Force Date: May 25, 2017
  • Date of Application of MDR (May 26, 2020) and IVDR (May 26, 2022)
  • MDD/IVDD CE Certificates Not Valid After: May 27, 2024

How can APS Regulatory Consulting Services Support your CE Mark:

  • Determining the classification, regulatory pathway, and applicable regulation (MDR/IVDR) for your device.
  • Performing a gap assessment of existing technical documentation that supports safety and performance against the requirements of the applicable regulation.
  • Compiling the necessary technical documentation to support the General Safety and Performance Requirements (GSPR), including device information, clinical evaluation, and risk assessment.
  • Evaluating or implementing an ISO 13485-compliant quality system.
  • Preparing for the Notified Body inspection of the quality system and review of the technical documentation.

The FDA requires foreign companies that want to market a medical device in the United States (US) to designate a US-based agent.

The FDA requires foreign companies that want to market a medical device in the United States (US) to designate a US-based agent.

APS can be your US FDA Agent:

  • Helps the FDA communicate with the foreign company and schedule inspections.
  • Responds to questions about the foreign company’s products.
  • Receives information or documents from the FDA on behalf of the foreign company (when the FDA is unable to contact the foreign company directly or in a timely manner).
  • It’s critical that your US Agent understands FDA regulatory requirements and has experience communicating with the Agency.

In addition to providing US Agent services, APS can help your company:

  • Communicate with the FDA.
  • Register with the FDA.
  • List your exempt and 510(k)-cleared medical devices
  • Update your required Establishment Registration and device listing
  • Identify any registration exemptions.
  • Determine if FDA Medical Device User Fees are required for your registration. If so, we will help you prepare and submit your payment.
  • Help you to obtain a Certificate of Foreign Government (CFG) from the FDA if your company wants to confirm it has a current, valid FDA Registration.
  • Submit and maintain your device listing with the FDA.

Your trusted resource for a full range of preclinical services.