MEDICAL AND REGULATORY MANAGEMENT
- WE CAN ASSIST YOU
COMPLIANCE AND MARKET SURVAILANCE
REGULATORY ASSISTANCE
A rapidly growing industry with complex rules and regulations
The medical market is growing rapidly. More and more possibilities exist and new market innovations in regards to surgical methods as well as technological possibilities are continuously appearing. In a market where clinics and hospitals offer everything from reconstructive surgery after breast cancer to face implants and stem cell liposurgery, suppliers of postsurgical care products need to intelligently cover a wide range of clinical indications and to innovate accordingly.
More than 50 years' experience with working with medical legislation
At Tytex we have more than 50 years' experience in working with medical devices. These experiences have left us with effective market surveillance processes — covering FDA, MDD and now MDR compliance — enabling our partners and us to adhere to regulations as well as stay ahead of the market demands and requirements.
Fill out the form on the right, if you wish us to contact you regarding future cooperation possibilities and if you wish us to help you become MDR compliant.
We adhere to and are certified according to the strictest medical requirements
Regulatory compliance — the competitive edge in the marketplace of tomorrow
As 2021 all of us in the medical industry have been facing new challenges. As the European Union has begun enforcing the Medical Device Reporting (MDR) regulations, many distributors and medical brands have been challenged in more ways than one. Your medical garments and textiles can be prevented from being sold or become recalled for a number of reasons. If your products do not comply with one of the many rules of market access, it may prevent you from selling your product entirely resulting in lost revenues, accounts, critical market shares and sunk cost on R&D investments. Your products can also be recalled resulting in large expenditures in shipping and handling as well as a large amount of time spent on diplomacy with external parties. At Tytex we know how legislation works and we are able to guide and assist you in relation to any legislative framework.
EU MDR.
The reasoning behind the introduction was the overall protection of the end user and the felt need to ensure that products marketed within the European Union did not do any harm to humans. Despite the fact that medical brands have been complying with REACH for a great deal of time, many have never had their products
certified under the new MDR regulations. The MDR regulations were adopted in 2017 and succeeded the EU Medical Devices Directive (MDD), yet many companies are now beginning to struggle in order to comply with the intricate legislation. We are able to assist you in navigating the complex rules and regulations and help ensure, that your products and assortments are all MDR compliant.
At Tytex we can help you become compliant
At Tytex we have — together with our customers — been preparing and have worked relentlessly to be ready for when MDR came into effect. Our specialists are well-versed in all the intricacies of the regulations and we are experienced in helping as well as ready and eager to assist all existing and new partners should they need any assistance in navigating the regulatory system and gain the competitive edge in the medical devices industry.
Please do not hesitate to reach out should you need any advice from us. We are willing and able to help your company become compliant in regards to any legislative framework.
The really unique features of our garments
4-way
stretch
The textile will adapt to the body shape at all times ensuring that the product will provide the necessary compression needed for recovery, as well as the best possible comfort at all times during prolonged wear.
Targeted compression
and support
Targeted compression and support means that our partners' products are designed to provide the necessary compression and support exactly where needed. By controlling compression on the scar tissue, the healing process advances faster and patient comfort is heightened. The compression zones are specially designed into each product based on indication.
Seamless
knitting
For optimum healing, the surgery site needs rest. That is why products from Tytex and our partners are designed to guarantee no seams in the wound or scar area and at any other critical sites of the applied area. This provides maximum skin friendliness and prevents pressure marks, as well as irritation of skin and tissue.
Fact-based
sizing
When it comes to medical textiles and post-op garments, no size fits all. That is why we base all sizes on three parametres; statistical body knowledge, comfort stretch measurements and extensive knowledge and experience with the combination of knitting methods in different materials. The combination of these 3 parameters ensures perfect fit at all times.
Important aspects to consider when designing medical garments and textiles
With more than five decades of experience in developing medical garments and textiles, we know just how challenging it can be to supply high-performance medical garments and textile solutions to hospitals, clinics and patients. Therefore we want to offer you advice and inspire you when we develop customised garment and textiles for your company so you can be successful when bringing your products to market.
Determining clinical indications
Knowing the implications of the clinical procedure preceding the postoperative care process is also crucial when creating a secure and effective medical garment and textile solution. For instance, breast augmentations with implants pose other challenges than augmentation by liposurgery, when it comes to applying compression and support to the surgical area after surgery. This in turn will affect the choice of design, compression zones, texture and fit. This in turn can also affect the legislative ramifications when marketing the end product.
At Tytex, we work closely with clinicians and other industry authorities to determine clinical indications and define intended use. In everything we do, we also apply cross-clinical insights and knowhow from many clinical areas — such as wound care and hernia. This does not only secure compliance with a diversity of global regulatory systems, it also enable us to work strategically with clinical evaluation and post-market surveillance to create the best possible garments with the best possible patient outcomes. We offer these insights as an integrated part of our collaboration with you.
Understanding intended use
Any kind of medical garment or textile such as bras, vests, pants, girdles and face masks may have multiple purposes in postsurgical patient care. Understanding the intended use and clinical indications is essential when deciding technology as well as composition, design, level of compression and other key properties of a specific garment. The final solution needs approval to be released on the respective markets it is intended for. Therefore it is of crucial importance to continuously involve cross-functional teams of specialist so knowledge about materials, design and manufacturing are aligned with current legislation.
Your benefits when working with Tytex
At Tytex we have more than five decades of experience in regards to developing and manufacturing medical garments and textiles. The extensive insight we have into all key properties regarding garments and textile solutions for the healthcare industry is what truly defines our DNA and when working with us you will be leveraging your brand and developing your product portfolio together with our experts and during this cooperation you will be accessing all our knowledge and insight into medical legislation and compliance. All products your products will be adhering to relevant legislative framework.