We offer ready-to-market medical devices for out-licensing.
Galena Pharma is an MDR-compliant specialized company that provides end-to-end services for medical devices, encompassing the entire lifecycle of a product. Our team of experts is dedicated to staying abreast of the latest legislative changes and advancements to ensure that our client’s products remain compliant.
As a legal manufacturer (CE holder), we take on the responsibility of fulfilling all the legal obligations required by law on behalf of our clients. Our services also include providing advice and information to our clients and conducting thorough technical documentation reviews and audits to ensure their medical devices comply with the EU market.
Our team of experts is well-equipped and prepared to assist you with your product.
MEDICAL DEVICES WE OFFER
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 optimize the range of product categories to best suit our client’s requirements.
Email us at sales (at) galena.fi, and we can review your requirements together to find the most suitable product for your portfolio.
MEDICAL DEVICE SERVICES WE OFFER
We provide a complete range of services for medical devices, which include:
- 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
- Composing 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 client’s behalf
Our comprehensive services cover the entire product development process, from design to the final release for sale.
We fully comply with the ISO 13485 standard, ensuring the highest quality and safety standards throughout each process stage. We also offer specialized services for sub-areas catering to our client’s needs and requirements.
Contact us today to learn more about our services and how we can help ensure the success of your medical device.