Preparation of Clinical Evaluation Reports (CER) and Plans (CEP) in accordance with MDD 93/42/EEC or MDR 2017/745, applicable MDCG and MEDDEV documents for all device classes, types and combination products.
Preparation of Biological Evaluation Reports (BER) and Plans (BEP) in compliance with the ISO 10993 series as well as other applicable guidance & regulatory documentation.
Our experts assist with the compilation of electronic Common Technical Documents (eCTD) for drugs or drug-device combination products. We are equipped to prepare all modules as well as the XML backbone structure.
IASON consulting's interdisciplinary team encompasses a wide array of skills, including toxicology services, pathology, immunology, and expertise in global regulations.
