At DRA, we’re here to help you prepare the technical documentation you need for your medical devices. Our specialists can take care of the writing for you, as well as handling literature searches and performing evaluations. Our team will deliver complete, well-written documentation that covers all the details required to demonstrate that your MD and IVD products are safe and effective, and meet the requirements of the CE mark.
Our technical documentation writing services for health technology include:
- Verification and validation reports
- Product information updates and proofreading
- Clinical evaluation
- Biological safety evaluation (ISO 10993)
- Risk management (ISO 14971)
- IVD performance evaluation
- Literature searches
- Data analysis
When you need to ensure that your products or your suppliers meet all the requirements and industry standards, DRA can do the detailed work for you. Our services include full support for your supply and supplier evaluations, due diligence and gap analysis, including reviewing existing technical documentation, reviewing your QMS, and translating, writing, compiling and updating documents and quality agreements.
Our team combines fluent language with expertise in different types of health technology and MD and IVD devices, as well as knowledge of administrative regulations, QMS documentation and the most recent Medical Development Coordination Group (MDCG) guidelines in use in Europe. Whatever the issue, they will be able to clarify it for you, from understanding registration and application procedures, to medical writing, marketing materials compliance, post-market surveillance, device vigilance and price and reimbursement matters. We’re always ready to help you find the best solutions for your MD and IVD products.
DRA Consulting is now PharmaLex Finland
As we are merging with the global service provider PharmaLex, our name has been changed to PharmaLex Finland.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.