CLINICAL RESEARCH FOR MEDICAL DEVICE COMPANIES
Clinical studies are an essential step in ensuring your product is safe and effective, and that it fulfills its intended use. Enfisa by clinical research experts provides clinical consulting and strategy services for pre- and post-CE clinical evidence collection for medical devices.
Clinical consulting and strategy for medical device companies
Enfisa’s clinical research team is 100% focused on medical devices. Our team of experts has decades of experience in providing guidance on clinical evidence collection requirements, designing respective activities, and conducting medical device clinical studies with European requirements. We help medical device companies develop their clinical strategy and provide solutions for clinical evidence collection activities.
Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• What is a Post-Market Clinical Follow-up (PMCF) study and when is such a study necessary?
• How is a PMCF study different from a clinical investigation?
• How do PMCF study requirements change under the new EU MDR?
A PMCF strategy outlined in the PMS plan is essential to maintaining compliance under the new Medical Devices Regulation (MDR 2017/745).
Unfortunately, many companies feel overwhelmed and confused by the new requirements. Enfisa's clinical team can assist with the planning of PMCF studies for medical devices.
PMCF studies are designed to identify the potential for residual risks of a CE Marked device, and to collect data and gain clarity regarding the long-term clinical performance of the product.
Circumstances that may require PMCF studies include, but are not limited to:
• To confirm the safety and/or clinical performance for a new indication for use or claim that has been CE-certified (approved).
• Significant changes have been made to the medical device or labeling, and your Notified Body agrees that no pre-CE-marking study is necessary.
• Risk classification of the device has increased.
• Post-market surveillance activities have raised questions about safety, clinical performance, or effectiveness.
• If pre-CE-marking safety and clinical performance study did not or could not sufficiently address certain aspects.
• If questions regarding long-term safety or performance, or risks already identified from other similar devices still need to be addressed.
• On request from your Notified Body or regulatory authority.
Enfisa can help you evaluate whether your products would not require a PMCF study. A discussion with your Notified Body may be necessary; we can assist with that as well.
Medical Device Clinical Research Study Audits and Quality Control
Almost all clinical investigations with medical devices require one or more reviews of documents, systems, and procedures. These are independent examinations of clinical trial data and activities (including the company’s own oversight of the clinical study activities, if applicable). The intent of these reviews is to ensure the capture, analysis, and reporting of data in accordance with the study protocol and other approved documents, and compliance with GCP, regulatory requirements, and Standard Operating Procedures (SOPs).
Enfisa can quality review to any of the following regulations or standards:
• Medical Devices Directive (93/42/EEC and 2007/47/EC)
• Active Implantable Medical Devices Directive (90/385/EEC)
• Medical Devices Regulation (MDR) (study documentation only)
• Good Clinical Practices (GCP)
• ISO 14155
Enfisa can also support you on getting ISO 13485 and ISO 9001 as well, please get in touch with us for more information.