Case Study
Supply Chain

Simplified Management of MDR & IVDR Documents for Streamlined Compliance

Smart Surgical Appliances needed an all-encompassing, cost-effective solution that would allow them to identify relevant standards and minimise risks.

Testimonial

“Because the notifications tell me what is changing or has been changed, I can quickly go into the system and see how it will impact the product.”

Smart Surgical Appliances Adam James, Smart Surgical Appliances

The People

A medical instruments start-up with no margin for error

Critical to the success of Smart Surgical Appliances is engineering products to exacting specifications and understanding fast-evolving standards.

Founded by Krupa Srivastava and Adam James, Smart Surgical Appliances needed a comprehensive compliance management solution that could make continuous adherence to standards more efficient and cost-effective.

The Challenge

How to stay one step ahead of evolving standards

Smart Surgical Appliances knew they needed a compliance management system that could give them continuous visibility of when standards were under review or due to change.

The nature of Smart Surgical Appliances' business – the design and manufacture of keyhole surgery instruments – meant that adhering to standards was integral to their operational viability.

They identified that the right solution should make standards easily accessible to all staff, stakeholders and relevant third-parties from a centralized location. It was also critical that a compliance management solution not only notified the organization of changes to standards, but could tell them when they were due to take effect ahead of time.

The Solution

The confidence to navigate change

With a user-friendly interface that empowered Smart Surgical Appliances to stay on top of evolving standards, Compliance Navigator transformed their approach to compliance management.

Unlike other solutions, Compliance Navigator offered Smart Surgical Solutions an early warning system that could update them on upcoming changes to standards. Identifying relevant standards by device type ensured less time spent researching, giving the organization confidence that products are being developed to the correct requirements.

Expert commentary within the software also helped development teams interpret whether a standard was right for their purposes and helped them assess the impact of any changes on their work.

Managing compliance with peace of mind

Get unrestricted access to an evolving set of regulations and standards for complete peace of mind.
Search by device or keyword to find every relevant standard for your product portfolio in seconds.
Save time performing gap assessments with expert commentary on changes to documents relevant to you.
Reduce the risk of recall with real-time notifications direct to your inbox about document changes.
Streamline compliance processes with a user-friendly platform that's accessible to your entire team.
Organize, co-ordinate and manage each user's document access with increased speed and efficiency.

The life-saving precision of laparoscopic surgery

13 million

13 million keyhole surgeries are performed globally every year.
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$13.6 billion

The market for laparoscopic devices was valued at $13.6 billion in 2020
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Testimonial

“Compliance Navigator provides that confidence that you are not missing anything that you may do if using other solutions or workflows.”

Adam James Smart Surgical Appliances

Why BSI

Accelerating opportunity for life-saving device makers

Helping companies worldwide stay compliant and grow their business.

Compliance Navigator is the only platform built by the experts with product manufacturers' needs at the heart of the platform.

Contact Us

Getting it right first time with Compliance Navigator

Find out how organizations can realize their growth potential with a more effective compliance management solution.

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