How we cater to the Medical Device industry
Integrated and compliant product engineering and lifecycle management.

We manage your MCAD, EE, and software engineering applications, supporting your FDA compliant design control procedure.

Validated applications and systems.

We incorporate and support CSV procedures in IT application and infrastructure management.

Quality Management System (QMS) implementation and management.

We can manage your QMS system and integrate with your product lifecycle process and applications.

Medical Device Summary

Medtech suffers from twin pressures. On the one hand you have to get your products to market faster than the competition or you’re playing catch up. On the other hand, you have to make sure everything is of highest quality and meets FDA regulatory requirements. These two challenges, plus increasing globalization and increasing product complexity can be a daunting task to say the least.

For 20 years we’ve been helping medical device and life science companies bring their cutting edge medtech to market while meeting FDA standards. We do that by leveraging our product engineering expertise, deep IT experience, and thorough knowledge of current FDA regulatory requirements. That means a more efficient development cycle for your organization.

For startup or SMB Medtech companies, we can provide fully outsourced IT managed services, if needed.  Wouldn’t you rather entrust your technology management to a partner that knows your industry inside and out?

Businesses that trust in SPK

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Let’s discuss your goals together, we make it simple.
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