Medical Device
MDR and IVDR Consultancy
We have deep expertise in medical device and diagnostics regulations, with extensive experience navigating the regulatory process for clinical trials and product approvals in the USA and EU.
Our clients benefit from our large collective experience when formulating and implementing regulatory strategies and study designs. Thanks to LaNova’s Medical flat management structure, this experience remains accessible and is never lost within a complex organisation.
Clinical Evaluation Services
We conduct or update scientific literature searches in line with the requirements of the MDR (EU) 2017/745 under consideration of the latest guidelines, which form the basis for a clinical evaluation.
Our experts first create a clinical evaluation plan ensuring that all the information we need for the report is available, following by creating the clinical evaluation report. To provide the required information and evaluations in a targeted manner, we apply the “clinical evaluation assessment report template”. We also consider the data of technically, biologically and clinically similar products to avoid gaps in the proof of suitability for the indications you have defined.
Person Responsible for Regulatory Compliance (PRRC)
With the introduction of the MDR and IVDR, the authorized representative is considered an economic operator and is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
The Medical Director of LaNova also acts as PRRC for some our of clients under the MDR and IVDR.
QMS implementation
We provide strategic compliance consultancy at every stage, helping SME Medical Device companies through all stage gates towards and beyond commercialization, consulting with them on anything that will impact the quality and compliance of the final product.
Our Quality Management Team also conducts internal as well as external audits, including those requested by clients.