Here is a sample list of what we (and our associate companies) can do for you:
(Last update: Nov 26, 2023)
- Training / coaching / auditing / consulting in all areas: Design, Manufacturing, Quality, Regulatory, Complaint handling, Software V&V, Risk Management, Remediation Projects…
- Risk Management – across all areas including Supply Chain
- Product design and development, Validation / Verification
- Prototype build
- Manufacturing scale-up including Validation / Verification and control points
- Software applications, design, development, testing, Validation and Verification
- Complete package of services for ISO 13485 / MDSAP / MDD Registration
- Setup of comprehensive and pragmatic QMS and SOPs
- Regulatory filings such as 510(K), De Novo…
- Complete Supply Chain Management System
- Auditing – Internal, Suppliers, Product, Process
- Finding talent, and Staff Development
- …more…
Complete set of services / coaching / implementation / training / consulting on the following standards / regulations:
- 21 CFR 820
- ISO 13485:2016
- MDSAP
- EUMDR
- ISO 14971
- IEC 62366
- IEC 60601
- …more
Improvement initiatives, skill development, cost reduction / avoidance, and more… for Medical Device, Pharma, and Biotech firms:
- Lean Six Sigma – Life Science Focus
- Robust Design and Reliability
- Quality by Design
- Design / Manufacturing Optimization
- SPC Deployment to Reduce / Eliminate Inspection
- Total Supply Chain Management including Risk Control
- Curricula Maps vs. Job Families
- Defect Reduction / Elimination
- …more…
If you don’t see it listed above – please call us at: (512) 560 8326 (or write is at info@thekpisystem.com) and let us discuss your specific needs
Here are some upcoming changes and important deadlines in the Medical Devices / Life Sciences area:
Medical Device Single Audit Program – MDSAP
Canada has indicated that starting 2019 – they will accept an MDSAP certificate in lieu of CMDCAS, and that the latter will be discontinued. MDSAP offers certain advantages to manufacturers via a reduction in audit burdens. It spans the requirements for your QMS, as well those of regulatory bodies from Australia, Brazil, Canada, Japan, and USA.
What we offer: Training, Auditing, Consulting / Coaching, and undertake Projects to ensure your Quality Management System meets requirements of MDSAP. Our training covers six areas pertaining to MDSAP; click here to see more.
ISO 13485:2016 Certification
This standard was released in 2016 and medical device companies will need to certify to this standard before the end of February 2019. It must be noted that prior versions of ISO 13485 and ISO 9001 were aligned, however that is not true any more with the current versions of the two standards. The ISO 13485 Standard is coming up for review / updates shortly.
What we offer: Training, Auditing, Consulting / Coaching, and undertaking Projects to ensure your QMS meets requirements of ISO 13485:2016
ISO 9001:2015 Certification
This standard was released in 2015 and companies holding certification to the previous version of the standard will need to certify to this standard before the end of September 2018. The new standard has more emphasis on Leadership engagement, Risk Management, and also a streamlined structure which aligns with other standards such as ISO 14001. ISO 9001 Standard is coming up for review / updates shortly.
What we offer: Training, Auditing, Consulting / Coaching, and undertaking Projects to ensure your Quality Management System meets requirements of ISO 9001:2015 with practical application of Risk Management.
Medical Device Directive and Medical Device Regulation (MDD & MDR)
Medical device manufacturers and distributors who sell products in the European Union were required to comply with the provisions of the MDD; however, MDR 2017:745 has been released, and a three year transition time clock (starting May 25, 2017) is now ticking. The MDR has significant differences compared to the MDD – for example: MDR covers Medical Devices, other products with an Aesthetic or non-medical purpose but with a similar functionality and risk profile, as well as Active Implantable Medical Devices. Thus MDR is more voluminous compared to MDD.
What we offer: Training, Auditing, Consulting / Coaching, and undertaking Projects to ensure your products and systems comply with the requirements of MDR.
The pathway through these standards and regulatory requirements can be tricky to say the least – let us share our expertise in assisting you navigate the same. You will save money, time, and have more peace of mind – enabling you attend to other important aspects of your business.
We are easy to reach, call us at (512) 560 8326, or, just send us your info, and we will be happy to contact you: