How Quality System Harmonization Supports Growth


Do any of These Quality System Challenges Sound Familiar?

“Me too” nonconformances or 483 observations occurring in different areas of the business.

“We do it this way” responses that differ by area when you ask employees how they execute quality system requirements.

“I didn’t know that” responses when asked about an organizational quality goal.

“How will we roll this out across the company?” when there is a need to transition to new requirements such as MDSAP, the new European Union medical device regulations, and ISO 13485:2016.… Read More

MDSAP’s Process-Based Audit Approach


The process of an MDSAP audit is very different from that of other audits. In this blog post, we will explore what makes the MDSAP audit approach unique.

Short-Term Pain = Long-Term Gain

The MDSAP audit may present an initial challenge for some companies. The MDSAP audit model uses a process-based approach and defines the required audit sequence, nonconformity grading, scoring mechanism, and time requirements per process. In addition, the auditors must examine regulatory requirements from multiple countries. While the MDSAP audit may be more difficult at first, the payoff is big: A single audit satisfies multiple regulatory authorities.… Read More

CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers

FDA QMS subsystems CAPA and P&PC

What can FDA’s data tell you? Sometimes you learn something new ‒ other times the data validates what you already know.

FDA’s CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers.

The data addresses findings related to five quality system subsystem areas: Corrective and Preventive Action (CAPA), Production and Process Controls (P&PC), Management Controls (MGMT), Design Controls (DES), and Document Controls (DOC).… Read More

FDA Proposes Expanding the List of 510(k)-Exempt Devices:
What You Need to Know

FDA 510(k) exempt update

What: On March 14, 2017, FDA published a formal notice proposing to make hundreds of Class II medical devices exempt from premarket notification requirements that necessitate a 510(k) submission.* Note that there are a few exceptions for specific indications of medical devices. All devices will still need to meet other FDA requirements, such as 21 CFR 820 Quality System Requirements.

We view this shift as allowing FDA to focus its limited resources on higher-risk products in the 510(k) premarket notification pathway as well as the increasing number of 510(k) and de novo submissions being received.… Read More

Assembling a Comprehensive Risk Management Approach:
A Case Study

Our customer, like many medical device manufacturers, had numerous risk management activities occurring in isolation. Risk management was addressed in design, manufacturing, validation, CAPA, complaints, and other areas, but there was no comprehensive process that served the business or could be articulated to an auditor. In addition, the company’s risk management files were static – the company was not updating the files with post-production, post-market, and other relevant data.

Through a combination of training and coaching, our customer’s in-house team learned how to build a systematic, dynamic risk management process and risk management files.… Read More

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