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Scilife for Medical Devices

The efficient and compliant way to get your medical device to market, fast

Rapidly obtain and maintain ISO 13485, gain full compliance, and ensure inspection-readiness
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Picture of a woman working on a 3D printer with a prototype of a medical device
 

Together, we can accelerate your medical device to market

You can count on us during every stage of your medical device processes, from the beginning of a design cycle right through to manufacturing and post-market surveillance. Accelerate your quality management processes but also solve non-quality related challenges within your organization with our end-to-end and all-in-one life sciences platform by your side.

Improve every facet of your
medical device processes

Screenshot of Scilife Platform with ISO 13485, FDA 21 CFR part 11 and GAMP5 stamps

Fast-track your way to ISO 13485 Certification

Dodge document anarchy through centralized document control and easily export documentation packages for regulatory approval to rapidly obtain ISO 13485 Certification. Finally adopt a clear risk-based approach to medical device design and development, enhance quality management efficiency and, ultimately, get your medical device on the market faster.

Effortlessly maintain ISO 13485 Certification

The next challenge after obtaining ISO 13485 Certification for your medical device is to retain it (effectively). Our platform is designed with medical devices in mind, and supports you in impeccable risk-based design and document management. Simply connect and export the documents you need in a couple of clicks. 

Total compliance with 21 CFR part 11 and GAMP5

Validating is costly and time-intensive. We offer fully validated quality management modules that saves that headache! Our software is pre-validated according to GAMP5 and 21 CFR part 11. Pick and choose the modules you need to build up a completely custom and fully cloud-based compliant system. Our software is frequently updated, so you can keep up with the most up-to-date regulations.

Easy Audit Success

We help you ensure inspection-readiness by safeguarding your product and quality management processes, critical in such a highly regulated industry. Risk assessment is infused into our platform, so you can rest assured knowing you’ll have a spotless audit trail at any time. From risk-proof design, to effective implementation of CAPAs, to compliant e-signatures and approval workflows, to painless assignment and follow-up of compliance trainings. Everything is transparent and traceable, all the time.

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Save time to invest in
life-changing research

Our all-in-one life sciences platform powers collaboration, lowers risk,
boosts performance and accelerates your medical device to market
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With you during the whole
medical device lifecycle

 

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Modules related to
Design & Development, and Verification & Validation

Document Control

Design & Development

Risk Assessment

Modules related to
Design Transfer

Quality by Design

Electronic Batch Record

Modules related to
Design Transfer, Device Production, and Post Market

Trainings 

Events

Change Control

CAPAs

Audits

Customer Stories

Join these innovative Medical Devices' organizations in transforming lives through science

Olfactomics Customer Story

Olfactomics streamlines its ISO 13485 - certified quality processes with Scilife

  • Effortless ISO 13485 certification and processes

  • Improved Operational and Management Efficiency

  • Improved Employee's Trainings

Confinis Customer Story

Confinis reduces costs based on time saving with Scilife

  • Improved Operational and Management Efficiency

  • Improved Employee's Motivation and Trainings

Additional Resources

QualityKick_Medical-Devices-Classification-Quality-Requirements-1

Risk Based Classification for Patient Safety

Scott Gottlieb, who served as 23rd Commissioner of  Food and  ...

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Top Five Scilife Features that Help You Earn ISO 13485 

Life Science companies are doing great things every day. The ...

QualityKick-EU-MDR-Readyness

EU MDR: Key Changes and Important Steps

The European Union Medical Device Regulation 2017/745 (EU MDR) came into existence on April 5, 2017. The EU MDR is a replacement of the ...