Clinical data is the key for your medical device to meet the transition from the Directive (MDD) to the new Regulation (MDR). In addition, for in vitro diagnostic devices the new IVDR will require more stringent clinical data.
Special conditions apply to the clinical development of medical devices. Therefore, it is wise to work with a company that can help you throughout the process and that are also specialists in the Regulatory and Quality for medical devices.
Our unique profile makes Key2Compliance® a “one-stop-shop” for all services in the development of medical devices and diagnostic products, when you select a partner.
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Key2Compliance® specializes in the clinical development of medical devices
The clinical development for medical devices is different compared to pharmaceuticals. The regulatory and market requirements for medical devices and diagnostics are unique and in transformation.
Key2Compliance® offers both complete solutions as well as selected functions and required to carry out the appropriate clinical trials in an efficient manner. Together with our customers, we can design the clinical development program from start to finish. In many ways, it is a teamwork where we together with the customer contribute to success.
Key2Compliance® strives to be different:
- 100% focused on clinical development for medical devices and diagnostics
- Flexible and adaptable to your needs, we work as a part of your team
- Experience from small, medium and large medical device manufacturers
- Ensures that you have a correct and well-founded clinical development plan harmonized with regulations and quality requirements
- Let us harmonize your clinical documentation- it is important to link your intended use, claims, clinical evaluations and investigations
- We know how to handle medical devices in all risk classes and both before and after launch
When you already have clinical data available on a product, then Key2Compliance® can collect and evaluate this data and compare it to relevant regulatory requirements and then to compile the information in a clinical evaluation report, and evaluate the need for a post-market-clinical follow-up (PMCF) activity. The clinical evaluation report is the foundation for your clinical development plan. Sometimes the marketing of an already established product needs the support of new clinical data. Also then, Key2Compliance® is the partner you can rely on.
Key2Compliance® is a full-service partner for clinical development. Our team of Project Managers, Monitors, CTAs, Statisticians, Data managers, Regulatory Managers, Medical Advisors and Medical Writers all work with a unique expertise in medical device and their quality requirements. We can support you both locally and globally through a established network.
Recording from PMCF webinar Dec 16th. with Robert Iosif and Paméla Stenström:
Post Market Clinical Follow-Up for a Medical Device
– How to reach MDR requirements →
Recording from IVDR-webinar Mar. 24th. with Johanna Fugelstad and Katalin Holenyi:
Performance Evaluation for an In vitro Diagnostic Medical Devices
– How to reach IVDR Requirements →
Please do not hesitate to contact us if you want our support.
Key2Compliance® helps you to:
- Conduct clinical evaluations and systematic literature reviews
- Design, manage and monitor clinical trials, according to your regulatory strategy
- Write applications to authorities and ethics committees
- Continuously document during projects and manage logistics
- Manage programming, data management and statistics
- Write minutes, reports and publications
- We have the attitude and knowledge that your medical product needs.
Teamwork with tailor-made solutions
Here are some examples of what collaborations in Clinical Development with Key2Compliance® may look like:
1. CE-marked product in class IIa under the Medical Device Directive (MDD): Received support with both biological and clinical evaluation for recertification. The work was carried out in close collaboration with the product manager and inventor/clinician and all documents were ready after 2 months. Notified Body approved after review without question. The product received a new certificate on site in time.
2. Class II product submitted for CE marking: The customer wants to strengthen safety data with a trial-Key2Compliance study at three sites in Sweden. Key2Compliance® is responsible for project management, monitoring and support with documentation.
3. CE-marked product (software): Responses to the Clinical Evaluation Report (CER) from Notified Body had resulted in a long list of questions to answer within 3 weeks. Key2Compliance® assisted in revising the plan and report with a new strategy and strengthened arguments. Back to Notified Body in time.
4. Launched CE-marked product: Requires data for marketing and reimbursement. Key2Compliance® supports with project management, statistical analysis and protocols (amendments etc). Ongoing.
5. Product under development class 1m: Key2Compliance® supported (approx. 8 hours per week) for 6 months. Clinical evaluation partly based on similar product and literature search was performed. New CE marking on site with only one clarification, without revision of CEP and CER.
It is the team that makes the difference
- Our experienced RA specialists help you build a RA strategy and secure that it is followed
- Thanks to our QA managers helping you with audits, you are always ready for inspection
- Studies are run and monitored by our competent Clinical Trial Leaders
- Our Medical Advisers support you in any medical issues
- When it’s time to compile, our Medical Writers write the reports, applications and articles