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DACAR ENTERPRISES

GUIDED
REMEDIATION

Leading your team with quality system documentation for manufacturers of medical device, pharmaceutical, and combination products.
Services

Integrated Services

Project Leadership

DaCar will provide dynamic project oversight, task management and resource optimization so that individual contributors and teams complete tasks efficiently and effectively to meet timeline expectations.

Project Task Identification and Management

Mapping, Planning and Timeline Management

Tracking and Resource Optimization

Identify Critical Path Activities and Execute Contingencies

Metrics, Dashboard Generation

Daily/Weekly Management Communique

Quality Management Systems (QMS)

Gap assessments are performed and utilized by DaCar to create Quality Plans aimed at areas for improvement thereby elevating company SOP’s (standard operating procedures) to today’s quality demands. Insightful leadership will then provide guidance and authorship to implement and integrate all aspects of regulations and standards to these SOP’s.

Risk Management
EN ISO 14971:2012, ISO 13485:2016

Design Controls
21 CFR 820.30, ISO 13485:2016

Design Change
21 CFR 820.30, 820.40, ISO 13485:2016

Complaint Handling and Coding
21 CFR 820.196, ISO 13485:2016

Nonconformance
21 CFR 820.90, ISO 13485:2016

CAPA
21 CFR 820.100, ISO 13485:2016

Mentoring

Transfer insights and knowledge on quality management systems using various training techniques sharing the fundamentals of standards, the application of standards as well as the how and why they satisfy the regulations.

One on One in Workplace

One on Many in Classroom/Conference Room

Engineers, Supervisors, Management

Classroom Lecture and Exercises

Training Assessment Testing

Tools

Understanding Tools

The Right Tool for the Right Job

Whether company lingo is old school or radically new, when referring to tools and terms, they all aspire to the same set of rules. Get the job done right, get the job done quickly and get back to full production mode. Some of the tools and terms you’ll hear along the journey are many and diverse. Understanding tools and terms and being able to “Apply” them is crucial to a successful project.

 

Tools and Terms to work by:
Leadership
QMS
Mentoring

 

DaCar is partnering with the Cognition Cockpit tool to offer a truly unique Quantitative Risk Management experience.

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Applications

Industry Applications

Remediation of Company Processes

“Remediation” sometimes has an unpleasant ring to it. Regardless of its driving force, i.e., audit finding, 483 observation, warning letter or human performance initiative, when embraced as a necessity, it can lead you to prominence that delivers product sustainability and longevity. Remediation is about elevating your company’s quality processes by aligning to current regulations and standards to ensure continued success. If you aspire to the Quality demands of today’s regulators then let DaCar help you pilot your goals.

Gap Assessments to CFR’s and ISO Standards

Quality Plans for the Vision Forward

Project Plans to Dictate Cadence

Dashboards to Optimize Resource Allocation

Metrics and Leading Indicators to Assure End Goals

Training to Self-Reliance

LEADERSHIP, IN-DEPTH KNOWLEDGE OF REGULATIONS / STANDARDS AND KNOWLEDGE TRANSFER EFFICIENTLY AND EFFECTIVELY

Projects

REMEDIATION PROJECTS

(April 2015 – February 2017)

Warning Letter/483 Risk Management Remediation

Industry Leading Urology and Pelvic Health Company as Risk Management Consultant and Project Manager – Architect, train and implement quantitative risk management process and manage resources and timelines for urology products’ Risk Management Files to support lifting FDA Warning Letter.

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(November 2013 – July 2015)

Audit Finding Remediation

Multi-billion dollar Medical Device and Pharmaceutical Company as Quality Engineer – Manage resources and timelines for combination products’ Design History File (DHF) and Risk Management File (RMF) Remediation compliant to 21CFR Part 4 – Combination Products. ­Project Lead of Quality Engineers (5), to perform DHF gap assessments, create design history…

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(March 2011 – September 2013)

Warning Letter / 483 Remediation

Global multi-million dollar In Vitro diagnostic Company in assays and assay instrument platforms as Global 3rd Party Risk Management Consultant – Train, mentor and implement risk management process compliant to ISO 14971 and modify Post-Market Notification process compliant to 21CFR Part 807 to support lifting FDA Warning Letter. (March 2011 –…

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(November 2012 – September 2013)

Risk Management Process Implementation

Innovative In Vitro Diagnostic Start-up Company of as Risk Management Consultant – Architect and implement risk management process compliant to ISO 14971 for new technology and instrument platform (November 2012 – September 2013) ­Project Lead working with Quality Director to establish Risk Management process Manage Resources and Timelines Project Task…

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REGULATORY COMPLIANCE IS A MUST:  UNDERSTANDING THE CONVERGENCE THAT IS HAPPENING BETWEEN 21CFR820.30, ISO 13485:2016 AND MEDICAL DEVICE REGULATION (MDR) 2017/745 GOES HAND IN HAND

Profile

Dacar Profile

Mark A. Magnuson | Senior Engineering Consultant

As the owner/operator of DaCar Enterprises, I am an engineering consultant with over 30 years’ experience in regulated industries. Accumulating substantial knowledge and experience on the use and integration of Quality Management Systems, I work closely with medical device and pharmaceutical companies on related CFR’s and ISO standards to help meet their objectives. Regulatory Compliance of Design Controls and Risk Management are at the heart of my expertise.

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Learning to Innovate

In my early days it was all about inventing, creating and forging patents. Learning to innovate, bringing a thought to life, making a functioning prototype from an inkling of an idea is exhilarating. Documenting a product’s lifecycle is an absolute must to ensure the idea makes it across the finish line and becomes a safe, effective and useful medical product. See some of my patent — my beginning.

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Contact

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