医療機器の開発

Dedicated insights and know-how to advance your med tech

Enable an optimized global regulatory stategy from preclinical to your product launch and beyond.

Access dedicated medical device consultants and the reach of our global organization.

Follow key ISO 13485 quality system requirements to simplify audits and reduce development burdens.

Work with our dedicated medical device development team.

Developing medical devices demands a particular set of skills. Global regulatory requirements are medical device specific, as are the specifics of protocol design and study conduct, quality systems demands and commercialization considerations. That's why Fortrea established a dedicated medical device division as part of our global CRO to consult and support you with the insights and experience needed to maximize the potential of your device.

Our partnership enables the scale and reach of our established global organization, giving you the strength and flexibility you need to proceed with confidence.

Optimize your development path, from end to end.

Our development support team, led by regulatory affairs professionals, works with you to create an optimized development path that meets your clinical and commercialization objectives.

This plan translates into the seamless flow of preclinical and clinical activities required for an efficient and successful product launch. And, because market considerations are infused into your plan, the evidence gathered will provide the edge you need in your product's target therapy area.

Once your product is on the market, we're here to help you meet changing regulatory requirements and post-market study needs in a cost-effective manner.

Drive medical device development with global regulatory expertise.

開発においては、医療機器の技術革新はもとより、それに伴う揺るぎない開発計画が求められます。また、有力なエビデンスと説得力のある価値提案も重要です。さらに、競合する優先順位とステークホルダーが持つ異なる価値の定義により、開発の各段階を最大限に高める創造的なコネクテッド戦略が必要とされます。 And, as evidence is gathered, it informs and iterates regulatory, reimbursement, clinical and post-market strategies.

コーヴァンスの規制関連担当者はいち早く行動し、規制コンプライアンスのあらゆる側面を検討して、お客様のデザイン、原材料、製造方法または財務計画に影響を及ぼしかねない潜在的な問題を特定します。世界中で積み重ねた規制当局との対応経験を活かし、コーヴァンスはお客様がターゲットとする市場で規制当局の承認を受けられるよう、的を絞った新たな戦略を策定します。

戦略

Regulatory strategy planning
Claims and labeling
Portfolio management
プロジェクト管理
Agency meeting support
Post-market clinical follow-up plan support
Design control support
Risk management support
Regulatory compliance consulting
Registration and licensing support

Writing

臨床評価レポート（CER : Clinical Evaluation Report）
CE Support: Tech file/design dossier
Opinion letters
Strategy documents
Agency responses
Audit preparation and support
483s and warning letters
Biological safety evaluation

Submissions

510(k)
De novo
FDA electronic medical device reporting
PMA
IDE
Q-sub

過去 5 年間の実績
We’ve been honored to serve as a CRO partner of choice partner of choice for our medical device and diagnostic customers as we've worked side by side with them to advance their product development.

740+

Global Clinical Device and Diagnostic Studies

3,500

治験実施施設

147,000

患者様

Our team handles the entire clinical process from start to finish including:

Clinical strategy
Clinical study design
Clinical study operations
Site selection and management
Site monitoring services
Database development and management
データ管理
Biostatistics consulting

Medical writing
データモニタリグ委員会 (DMC：Data Monitoring Committee)/データモニタリング安全性委員会 (DSMB：Data Safety Monitoring Board) の管理
臨床事象判定委員会 (CEC：Clinical Events Committee) の管理
Clinical compliance/auditing
Inspection preparedness
Training with the sponsor and sites
臨床評価レポート（CER : Clinical Evaluation Report）

Enable efficiency across your medical device development.

すべての治験は独自の特性を持ち合わせており、熟考された治験デザインと実施により、お客様のデバイスに対する安定した科学的エビデンスを効率良く取得できます。 Combined with optimized study execution, we will deliver the evidence you need for your submission, while saving you time and money during the operational phase of your project.

Our advisors' deep experience can help you to identify ways to improve efficiency and, where possible, reduce your timelines. They will also work with you to pivot your strategy if unexpected findings occur. Let us partner with you from beginning to improve efficiency and speed your time to market.

Understand how we navigate complexities with an integrated approach.

Download our medical device development journey map (PDF)