MCRA advises leading dermatology and wound care technology companies throughout the product lifecycle.
Bringing Wound Care & Dermatology Products to Market
It can be challenging to bring new wound healing devices to market even under the best of circumstances. Though when factoring in industry-wide staffing shortages and intense regulatory scrutiny, many companies find their obstacles almost insurmountable.
Not only do they need to pay close attention to quality control and efficiency, but they also must have the expertise required to set up and manage clinical trials and navigate the complex regulatory environment. Given these challenges, it’s not surprising that many companies within the wound healing devices market find themselves overwhelmed and under-supported.
Our Experience in Wound Care & Dermatology Products
The extremely diverse nature of wounds makes the treatments associated with them exciting and ever-changing. Wound care and dermatology technologies can range from the simplest to the highest classification and include tremendous variation in both use and complexity. MCRA's proprietary system of combining our integrated services in clinical trials lends itself very well to the wound care technology lifecycle.
Our team of dedicated dermatology and wound care consultants bring a considerable amount of experience to help ensure a smooth journey from concept to market. We have the knowledge and know-how to guide our clients in every aspect of the process, helping grow their business into new markets and avoid many of the most common pitfalls that can create setbacks along the way.
Common dermatology and wound care device consultations include technologies ranging from:
- Dressings
- Rinses
- Films
- Gels
- Sutures
- Fillers
- Hemostats
- Tissue Adhesives
- Animal-Derived Products
- Combination Products
The expertise we bring in wound-healing technologies makes us the leaders when it comes to supporting clinical studies. Companies that create wound care and dermatology products count on us to deliver capabilities including global regulatory expertise, reimbursement and market access, quality assurance, CRO services, healthcare compliance, and cybersecurity.
Our clients know they can trust us when developing dermatology and wound care devices because our vast portfolio of services will assist them every step of the way. In everything we do, our objective is to help them achieve their wound and care and dermatology product development and commercialization goals. This means we work closely with them throughout the innovation process, from ideation all the way through to market.
Our Team
Having the right experience behind the development of wound-healing and dermatology devices is crucial. Our wound care consulting specialists have the knowledge and expertise to help our clients take on projects of virtually any size or complexity.
Meet our talented industry experts.
Wound Care & Dermatology Device Resources
Wound Care & Dermatology Device Services
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Wound Care & Dermal Clinical Research Organization (CRO)
Our dedicated staff, first-class facilities, and proven expertise mean we can offer full support of clients’ devices as they bring them to market. With our wound care device consultation, manufacturers can rest assured that they will have the most successful development process to ensure a hassle-free launch.
Learn more about our wound care and dermal CRO services here.
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Wound Care & Dermal US Regulatory
We understand the complexities of the FDA regulatory process, enabling us to guide devices through it with success. Our comprehensive expertise means our clients won’t have to worry about achieving approval or encountering any surprises along the way.
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Wound Care & Dermal Global Regulatory
Introducing devices to international markets requires a lot of strong regulatory and scientific leadership, both of which we bring to the table. We help open new doors within the wound healing devices market around the world, giving our clients the opportunity to grow their businesses in ways they didn’t think were possible in the past.
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Wound Care & Dermal Reimbursement, Health Economics, and Market Access
We have more than 50 years of experience when it comes to reimbursement, health economics, and public policy services. With the help of our extensive knowledge base, manufacturers can feel confident about their revenue streams knowing we will explore every available avenue.
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Wound Care & Dermal Quality Assurance
Clients trust us to ensure all proper procedures for document control, R&D, risk management, software development, supplier evaluation, control of measurement equipment, and more are in place and being followed. Our goal is to give our clients total confidence in their products by ensuring what they bring to market will be of the highest quality.
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Wound Care & Dermal Healthcare Compliance
Our experts ensure that new devices are guided successfully through the increasingly complex legal and regulatory environment of today. Even a minor compliance issue can be devastating to the development of a new product, and our wound care consulting services prevent them from standing in our clients’ way.
Learn more about our wound care and dermal compliance assistance here.
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Wound Care & Dermal Cybersecurity
Protecting advanced medical devices from cybercrime and data breaches is more important than ever, and our solutions offer the highest levels of security. Companies count on us to seal any gaps that may exist in their devices’ cybersecurity.