Contact Us
7040 Avenida Encinas Ste 104 Carlsbad, CA 92011
Team@AskMedDev.com
(805) 624-9834
Providing Clients Robust and Effective Solutions for Software Compliance and Risk Management in the Medical Technology World.
Ask MedDev Consulting provides our clients with solutions for their most challenging software efforts. Whether you’re a start-up requiring additional bandwidth to support your submission or a well-established Fortune 500 firm requiring effective and efficient means to resolve remediation matters, we have a solution for your situation. Our experts have worked in the industry for over 30 years and have dealt with Class I - III products throughout their careers.
Consulting Expertise
We will provide you fully developed strategy and tactics for your Medical Technology’s regulatory compliance and quality needs. Our experts will provide you with solid solutions to the issues you come across in your organization.
1
Assessments/Auditors
If you are looking to obtain an independent assessment of a supplier or your system, processes, and procedures, then let us come in and provide you with an unbiased view.
2
Cybersecurity
Your company’s reputation could be put at high risk in this age of constant cyber-attacks on our infrastructure, hospital facilities/structures, and product data.
3
Design Control
We have successfully released scores of products from Class I – III under varying strategies in order to leverage organizational sources and provide the best speed to market result.
4
Remediation
We have led DHF remediations large and small. By performing a thorough needs assessment and analysis, we could save you literally thousands
5
Design Verification ...
Need assistance in developing a master validation plan or to review and hardened your approach test strategy, let us offer you our guidance.
6
Independent Reviewers
We are able to come in and perform the code-level reviews, test strategies, and challenge design deliverables.Or maybe one truly needs an unbiased expert assessment
7
Risk Management
Practical, realistic, and full-proof risk analysis requires real-world experiences. Too often, software risk management is performed without a true direction
8
Submission Support
Assist in preparing the software documents for 510(k), PMA, and IDE Submissions including; Procedures, Plans, User Needs, Requirements, Specifications, Hazard/Risk Analysis
9
Unit Acceptance Testing ...
Providing users with a positive experience is the goal of user acceptance testing and the Human Factors experience.But ultimately, one wants to deliver the right product
10
Product Lifecycle Manage...
Looking to automate your engineering, change control, and document control activities. We have been at the forefront of developing world-class PLMs in Oracle Agile, Windchill, Arena Applications, etc.
11
Business / QMS Software ...
Need assistance in developing a validation plan to get your system operational, let us offer you our guidance. By providing you with an appropriate level of test coverage, you’ll have a robust test strategy
12
QMS Solutions
Managing CAPAs, nonconformances, and complaints manually or in cryptic excel files is time-consuming and prone to error. By choosing the right system and leveraging its scalability
“We must all obey the great law of change. It is the most powerful law of nature.”
– Edmund Burke
News
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
Create the right solution. Most organizations either perform overkill or nothing
ASK MedDev Consulting
7040 Avenida Encinas Ste 104 Carlsbad, CA 92011
Team@AskMedDev.com
(805) 624-9834
We started our careers in the industry when both the FDA and Europe started taking a harder look at Design and Development. We offer practical service solutions to your development and remediation efforts.