Regulatory Compliance and Clinical SOLUTIONS
Regulatory and Clinical Solutions
The orthopedic medical device industry is rapidly evolving, with Regulatory and Clinical demands becoming increasingly stringent. To navigate this global landscape with confidence, Resolve Surgical Technologies offers comprehensive support as part of our Contract Design Manufacturing Organization PLUS (CDMO+) business model. This model includes both a wholistic global approach to new product development, including Clinical and Regulatory standards, as well as supplemental Regulatory and Clinical consulting services for existing product lines.
- 510k Writing and Submission Services
- European Union Medical Device Regulations (EUMDR) Compliance
- United Kingdom Conformity Assessed (UKCA) Compliance
- Global Regulatory Compliance, Registrations, and Certifications in most countries
- Change Impact Assessments
- Technical File Updates
- Submission Strategy and Composition
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Post-Market Clinical Follow-up (PMCF)
- Summary of Safety and Clinical Performance (SSCP)
- Systematic Literature Protocols and Reports
Regulatory and Clinical Services
Our Regulatory services encompass global strategy and submission compilation including United States 510(k), Health Canada Licensing, and European Union (MDR), United Kingdom (UKCA), and Australian Technical Documentation. Clinical services include strategy to ensure conformity with local regulations, principles and requirements. Writing services including Clinical Evaluation Plans, Clinical Evaluation Reports, Systematic Literature Protocols, Systematic Literature Reports, Post-Market Clinical Follow-up (PMCF) and Summary of Safety and Clinical Performance (SSCP) documents.
Globalizing Your Portfolio with Ease
Let Resolve guide you through the complexities of regulatory and clinical requirements. Our goal is to simplify the process of portfolio globalization, keeping your business ahead of the curve.
Collaborate With us
We are always looking for new opportunities to collaborate and innovate with external partners to help improve patient lives. If your company is looking for a partner to accelerate innovation and speed to revenue, please fill out the following form. Do not submit confidential or proprietary information through this form.