FULL-SERVICE SOLUTIONS FOR MEDICAL WRITING
We offer full-service solutions for Medical Writing, ranging from Clinical Evaluations to Scientific Publications and Medical Marketing.
Our medical writers have PhD degrees in a variety of areas; regenerative medicine, cartilage research, anatomy, biomaterial, biochemistry, pharmaceutical science and cell biology, and have published numerous scientific publications and regulatory documentations. We know what guidelines to follow and are members of the European and American Medical Writing Association.
In the hands of Clinical Experts
Devicia has a broad range of clinical experts within a variety of disciplines who can write manuscripts and act as Clinical Evaluators for European Clinical Evaluations.
Furthermore, our Quality Management System is specifically tailored for the requirements for medical devices. When writing clinical evaluations, we always consider the latest guidance available.
We guide our clients through all steps needed and make the journey from product idea to market introduction swift, transparent and agile.
Our services includes:
- Clinical Evalutions (MEDDEV 2.7/1 Rev.4, MDD 93/42/EEC, MDR 2017/745, MDCG 2020-1, MDCG 2020-13)
- Clinical Investigation Documentation (ISO 14155, MDD 93/42/EEC, MDR 2017/745, 21 CFR Parts 50, 56, and 812)
- Post-Market Surveillance (PMS Plan, PMS Report/PSUR, PMCF Plan, PMCF Evaluation Report)
- Summary of Safety and Clinical Performance (MDCG 2019-9)
- Scientific Publications (incl. peer-reviewed journal abstracts)
- Pre-Clinical Research Documentation
- Reports for HTA and Reimbursement Submissions
- Medical Marketing
- Quality Management System Documentation, incl. Standard Operating Procedures”
GET IN CONTACT
Whether you have questions regarding regulations, clinical strategies, educations or need help with an audit, you are always more than welcome to contact us.
Our ecosystem for full-service medical device compliance
We are your full-service medical device partners. Together we offer unique expertise regarding Quality Assurance, Regulatory Affairs, Clinical Affairs, Biological Evaluations & Toxicology.