Why off-label data should not be ignored
Why off-label data should not be ignored
Use it or lose it: Why off-label data should not be ignored! Danielle Giroud and Erik Vollebregt discuss the challenges and opportunities of using off-label data to expand the intended purpose of a medical device under the MDR.
Risk Management for Medical Device Clinical Investigations - 8 Part Series
VIDEO SERIES
Risk Management for Medical Device Clinical Investigations
Join us for this fascinating series of in-depth discussion, analysis, and expert insight on Risk Management for Medical Device Clinical Investigations presented by renowned industry experts, Danielle Giroud, Dr. Maria E. Donawa, and Dr. Bassil Akra.
Part 1:
What are the common mistakes companies are making before developing a clinical investigation design?
Part 2:
What are the common mistakes companies are making before developing a clinical investigation design?
Part 3:
What are the common mistakes companies are making before developing a clinical investigation design?
Part 4:
What are the common mistakes companies are making before developing a clinical investigation design?
Part 5
Integrating Risk Management into a Clinical Development Plan and Study Design
Part 6
Integrating Risk Management into a Clinical Development Plan and Study Design
Part 7
Integrating Risk Management into a Clinical Development Plan and Study Design
Part 8
Integrating Risk Management into a Clinical Development Plan and Study Design
Current experience update of remote monitoring in SE-Asia
Current experience update of remote monitoring in SE-Asia
Remote monitoring, when applied under a risk management process in the planning of a clinical investigation, can be a useful tool in addition or in lieu of onsite-monitoring. Although early experience showed some resistance which gradually went away with forced remote activities during the pandemic, we see that with the necessary flexibility in applying tailormade solutions for the sites, remote monitoring becomes a quite appreciated monitoring solution. Ivon Septriyana provides some tips and tricks on applying remote monitoring in SE-Asia studies with medical devices.
Swiss Authorized Representative
Swiss Authorized Representative
Your passport to medical device and IVD market access in Switzerland.
Switzerland no longer has a mutual agreement with the EU. As a result, all medical device manufacturers wanting to keep or place their products on the Swiss market are required to appoint a Swiss legal representative.
We offer a highly compliant and professional service that helps manufacturers bring products successfully to the Swiss market.
Our clear and simple approach:
Step 1: Verification
After signing an NDA, we will ask you for access to high-level documentation to verify whether it is feasible for us to be your representative. For this we request the following documents:
- Early determination of clinical development plan for global market access
- CE certificate and ISO 13485 certificate
- Your product liability insurance policy
- A risk management file, clinical evaluation file (including PMS/PMCF plan/reports), IFU, and labeling of a representative product or product group
- Your SOP on the authorized representative process
Upon validation of verification, we will provide you with our standard agreement.
Step 2: Before getting started
We will need proof of an updated product liability insurance policy covering MD-CLINICALS as an authorized representative. This is an important step as we will be taking local responsibility for your product on the Swiss market.
Step 3: Signing and getting started
After receiving the final insurance policy, MD-CLINICALS will countersign the agreement and we are then ready to get started. You will receive our local registration number for adapting your labeling. We will proceed with a full review of your file before registering your product with Swissmedic. For this, we will provide you with secured access to a local server where you can provide us with up-to-date documents from your product technical file.
After a review of the appropriate documents in your technical file, we will proceed with the registration of your product(s) in the Swiss medical device database.
For further inquiry, please contact SwissAR@md-clinicals.com
Regulatory Affairs
Regulatory Affairs
Finding the right regulatory strategy and troubleshooting an existing strategy is something we take very seriously. It is essential to build a strategy integrated with the business strategy and eliminate as much uncertainty as possible. Through an extensive network with regulators and notified bodies, predictability is what we are striving to achieve for our clients.
Our team of regulatory and quality experts adopt the most cost-effective approach in compliance with local regulations to get your medical device registered rapidly and efficiently. We also offer a range of industry-leading services designed to optimize the positioning of your product.
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Global
- Worldwide regulatory and clinical strategy
- Define pre-clinical strategy and implement
- Support with preparing technical file
- Risk Assessment process
- Market access regulatory processes worldwide, contact us for inquiries on your target countries
Europe
- Troubleshoot matters with notified bodies or regulators
- Notified body selection
- Authorized Representative Services under MDR/IVDR (IVDD and MDD till switch to MDR/IVDR)
- MDCG expert panel meetings (as soon as operational)
- CE-mark process support
USA
- 510K and PMA submissions
- IDE submissions and pre-sub meetings where needed
- Breakthrough device program applications
China
- NMPA green channel process
- NMPA submissions and related meetings
- Prepare and manage pre-clinical type testing
- Legal representative
Medical Writing
Medical Writing
We provide you with high-quality documents to ensure successful review by regulators, notified bodies or publishers.
Clinical and regulatory medical writing
The key to a successful regulatory submission lies in the technical expertise of the managing team. Our medical writing specialists possess not only the required medical device regulatory and clinical expertise, but have also acquired years of hands-on clinical experience throughout a multitude of medical and therapeutic areas.
From a regulatory perspective, clinical evaluation plans and reports need to demonstrate relevant clinical evidence in order for a medical device to access or maintain its place on the market. That’s why our experienced regulatory writing professionals deliver effective and compliant documents for submission by manufacturers to their notified bodies.
Having developed hundreds of clinical investigation protocols and reports, we also offer services in both clinical investigation design and documentation writing for pre-market and post-market clinical follow-up of your medical device.
We can help you:
- Define/refine the claims of the product for efficient development of the clinical evaluation process for successful market access or maintenance of CE mark.
- Successfully transit from MDD to MDR.
- Meet the deadlines for CE-mark by careful planning and preparation of the clinical evaluation process.
- Input to practical post-market strategies based on clinical evaluation findings.
- Formulation of a feasible and practical Clinical Development Plan to support the manufacturer’s clinical investigation plans/future global strategies.
- Step-by-step approach, validated with our customers to avoid misinterpretations and ensure efficient workflow.
Clinical evidence / clinical evaluation: Do you have the right flow?
We support you with getting the information flow in the right order to produce meaningful and compliant clinical evidence reports.
PMCF
Post-Market Clinical Follow-up (PMCF) Activities
Many manufacturers face the fact that they are lacking clinical evidence even for devices that have been on the market for many years, at the risk of losing the CE-mark.
Conducting PMCF may represent significant budgets for medical device manufacturers to the point that some are weighing the burden against withdrawing their devices from the market.
MD-CLINICALS specialises in setting up rationalistic plans for PMCF to optimize costs while still delivering the necessary clinical evidence through solid data and keep devices on the market in compliance.
Come and talk to us about our expertise with quality post market surveys as a cost effective alternative to clinical investigations, where possible.
Before you risk losing the EU market:
