Sierra Labs

09/18/2023

Take advantage of the efficiency of automation and reclaim your precious time! Say goodbye to laborious manual duties and concentrate on what truly counts with Sierra QMS. Initiate your journey today by enrolling in a complimentary trial.

This quality management system is designed to be a centralized hub for your entire organization. It is specifically developed to support agile teams and accelerate product development.



https://hubs.li/Q022z-Gz0

09/14/2023

If your team is in the process of developing a medical device, it is crucial to have an integrated tool for managing suppliers. Sierra QMS offers a comprehensive solution that allows for:

• Ongoing supplier communication
• Quality and safety measures
• Third-party audits
• CAPAs and non-conformance

Learn more: https://hubs.li/Q0229GNk0

09/14/2023

Spotlight!

recently received FDA 510(k) clearance for their system, making it the inaugural and exclusive robotic guidance and placement system approved for operation within an MRI bore. The IGAR technology platform has the potential to be modified for effortless transitioning between various care settings. This includes moving from an MRI to a regular operating room or even a physician's office.

Check them out: https://hubs.li/Q0229HKY0

09/13/2023

Spotlight!

Proov Test by MFB Fertility, Inc. provides the sole FDA approved home test for confirming successful ovulation using PdG. The tests offered by Proov have been authorized by the FDA, enabling women to obtain crucial hormonal information without having to visit the doctor's office for a blood test.



https://hubs.li/Q0228r7L0

09/12/2023

Creating efficient Standard Operating Procedures (SOPs) enhances the efficiency of your quality management and ensures compliance. However, what is the process for drafting an SOP? We have developed a straightforward guide to help you write SOPs that are both clear and concise, thereby simplifying FDA submissions.

Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies

09/11/2023

Utilize the potential of automation and liberate your precious time! Shift away from laborious manual procedures, enabling you to prioritize what truly counts with Sierra QMS. Commence your journey today by enrolling in a complimentary trial.



https://hubs.li/Q021QX930

09/08/2023

Simplify the challenges of adhering to regulations with Sierra QMS. Discover the potential of Sierra QMS in pushing your medical device development compliance objectives to new heights. Begin your free trial!



https://hubs.li/Q021GjY20

09/07/2023

Medical device developers can receive valuable feedback from the FDA prior to submitting their products through a service called FDA Pre-Submission. Despite its benefits, this resource is often underutilized. There are numerous reasons why you should consider leveraging this resource before submitting your application. This guide will explore the origins of this tool and provide guidance on how to effectively use it for your medical solutions.

Is there a way the FDA can give you feedback on your device, before submission? Yes, yes there is! The FDA Pre-Submission is a great service for companies to request feedback from the agency on potential and planned medical devices, biologics, or drug submissions.

08/31/2023

Spotlight! Check out Reperio Health:

This medical device company, located in Oregon, offers the sole at-home health assessment that delivers results for blood pressure, cholesterol, glucose levels, and other measurements in under 30 minutes.

Reperio offers the only at-home biometric screening with instant results and 24/7 live support.

08/30/2023

Planning a quality roadmap for your medical device?

With Sierra QMS, your team can strategically plan your path to achieving high-quality standards, guaranteeing that you meet all compliance milestones within your preferred timelines. Simplify the process of obtaining approvals, certifications, and undergoing audits by following a practical, step-by-step implementation strategy.



https://hubs.ly/Q020szdX0

08/29/2023

Every Healthcare and Life Sciences company must maintain a unique level of organization according to the quality objectives of their products. The specific SOPs, Policies, and Procedures employed by these organizations may vary depending on their size and development requirements. But what is the common denominator among all these companies? Establishing a comprehensive and well-structured quality management process is necessary to ensure compliance with relevant regulations and standards.

Learn the importance of integrating various regulatory compliance tasks into a single comprehensive platform by referring to our guide below.

Why it is imperative to incorporate a wide range of regulatory compliance tasks into one comprehensive platform.

08/28/2023

To guarantee audit compliance for your medical device, it is essential to keep detailed documentation of design changes and activities. With Sierra QMS, your quality team can:



https://hubs.li/Q020rW1q0