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An integrated, best-in-class commercial approach

Certara’s MedTech specialists partner with medical device and diagnostic clients to reduce risk and accelerate approvals using advanced technology, an integrated approach, and industry-leading expertise. At any stage of the product lifecycle, our team of experts leverages extensive experience and knowledge of medical writing, regulatory pathways, commercialization, and lifecycle management to provide the unique support you need to advance your program and increase regulatory success.

Our Solutions

As an extension of your team, we are uniquely positioned to anticipate and avoid risks, provide concrete insights to drive informed decisions, and deliver success for your MedTech program.

Deliver end-to-end consulting support

Our medical device experts perform gap assessments and clinical/performance evaluations to analyze risks and provide strategic input, ensuring you are prepared to meet evolving regulations.

Navigate global regulatory complexities

Medical device regulations are changing around the world. Our experienced team takes the guess work out of compliance with MEDDEV 2.7/1 Rev 4, EU Medical Device Regulation (MDR) 2017/745, In Vitro Diagnostic Regulation (IVDR) 2017/746, Brexit, and MDCG guidance documentation.

Elevate technical documents for submission success

Whether your documents need to be created or updated, our medical and scientific writing team delivers high-quality assets for your submission.

  • Clinical Evaluation Plan (CEP) / Performance Evaluation Plan (PEP)
  • Clinical Evaluation Report (CER) / Performance Evaluation Plan (PEP)
  • Literature Search Protocol
  • Literature Search Report
  • Post-Market Surveillance Plan
  • Post-Market Surveillance Report
  • Post-Market Clinical Follow-Up Plan
  • Post-Market Clinical Follow-Up Report
Certara Angela Siebeneck
Angela Siebeneck, MSN RN Director, Regulatory Strategy and Policy

Siebeneck 氏は、病院で正看護師としてキャリアを開始し、30 年以上の臨床および規制に関する経験を有しています。規制戦略、臨床およびメディカルライティングでの広範囲にわたる経験があります。薬事承認に関する経験は、欧州、オーストラリア、米国、アジアに及びます。テクニカルファイル、臨床成績評価、製造販売後調査 (Post-Market Surveillance:PMS)、製造販売語臨床追跡調査 (Post-Market Clinical Follow up:PMCF) 計画および報告書を含む、複数の承認申請のオーサリングを行い、貢献してきました臨床経験は、血管アクセス、整形外科、介入的画像診断、外科集中治療、外傷、在宅医療に及んでいます。

Your Success Starts Here

Ready to discover how our experts can accelerate your program? Contact our team now to get started.
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