Galena Pharma specializes in the complete lifecycle service of medical devices. We are closely following developments in the field and changing legislation.
On behalf of our clients, Galena Pharma can work as a legal manufacturer (CE holder) in handling the obligation of the manufacturer required by the law. Our experts can advise, inform and ultimately carry out any necessary technical documentation review and auditing required for your medical devices to remain compliant for the EU markets.
Our expert team is ready for your product!
We offer a comprehensive service for medical devices as follows:
- Design, product development and product maintenance
- Testing, such as shelf life tracking, physical tests, chemical analysis, microbiology
- Preparing and maintaining technical files
- Risk analysis, reviews and clinical evaluations
- Preparing biological and chemical evaluations
- Demonstrating equivalence
- Certification with the notified body
- Regulatory notifications and registrations
- Manufacturing and packaging operations
- Final inspection and release for sale
- Post-market surveillance (device safety)
- Clinical documentation (CER, PMCF, PMS, PSUR)
- Acting as the holder of the CE marking on the customer’s behalf
We can offer the full service, from design up to releasing the finished product for sale or individual sub-areas.
We operate as required by the ISO 13485 standard.
Our operations currently cover the design, manufacture, final inspection and sales of the following types of medical devices:
- Gastrointestinal gas suppressants
- Skin moisture barrier dressings
- Wound cleaning solutions
- Stool softener
- Lactic acid-based products for vaginal mucosa protection
- Oils for dry and irritated vaginal mucosa
- Ointments for damaged skin
We can expand the range of product categories according to our client’s requirements.
For more information, contact our expert or fill the contact form.