The 3CPM Company
“ As a small medical device company CEO, it would be an understatement to say we have been pummeled and abused by the regulatory process, complicated by the difficulty of finding someone, anyone, that could help us understand the processes and yet still be able to take care of business. Today I can honestly tell you that Salman Raza at Razalutions, represents the life raft we have all be searching for to help navigate the treacherous seas of regulation that threaten us all. Within minutes of meeting with the staff, everyone felt at ease, in better command of the tasks at hand and that familiar feeling of hopelessness had disappeared. “
Mr. Mark Noar
CEO, The 3CPM Company
Adagio Medical & Founder of Fjord Venture
“Salman is one of very few regulatory consultant and auditor who explains regulations in the context of the organization. In our previous experience, we had too many auditors and consultants solely focusing on regulations and telling us what must be done with rigid attitude. However, Salman displayed a unique ability to understand our product, scale of our operation and found the optimum quality and regulatory solution that not only aligned with our business model but also met all regulatory requirements. He brought such an energy into conversation that even dry topics of ‘Quality & Regulations’ felt like a best-seller; and this attitude is noticeably contagious in his presence. His depth of knowledge and admirable interpersonal skills make every interaction an insightful and pleasurable experience. I can confidently recommend his high quality, professional work. If you’re working with him, I can say for sure that you are in great safe hands.”
Mr. Olav Bergheim
CEO, Adagio Medical & Founder of Fjord Venture
Tech4Life Enterprises, Canada
“Razalution provided wonderful service in training our staff and preparing our organization for ISO 13485 and CE audits. We have worked with other consultants before, but the quality of guidance and support received from Razalution in preparation for the audits and responding to the queries was unmatched by anyone else. Highly Recommended”.
Dr. Shariq Khoja, MD PhD
CEO- Tech4Life Enterprises, Canada
CIMA Technology, Inc. PA, USA.
Razalution provided us MDR Transition training. I thought the training course was great. Our trainer ‘Salman’ is very knowledgeable, and all of the handouts and printed materials were very helpful.
We found the MDR binder with the added index extremely helpful. We learnt a lot and feel a lot more confident as we are moving forward and beginning to update our documentation.
Matt Stoner, Quality Engineer
CIMA Technology, Inc. PA, USA.
MVS Operations Leader at GE Healthcare
Salman was the lead auditor when my company went through the transformation into ISO 13485. He had an excellent level of knowledge, twinned with the experience to back it up. I found Salman a great communicator and very much put my team at ease when delivering his findings. He offered much more in the terms of risk management which benefitted our company tremendously. Salman was a pleasure to work with.
Nigel Gowland MSc IIPEM
MVS Operations Leader at GE Healthcare
June 25, 2014, Nigel was a client of Salman’s
Mr. Raza assisted the company during this process as a very professional lead auditor. He has a way of approaching a difficult task as this in a very balanced way. He fully understood the difficulties that the other side (the company) has to consider as a commercial unit and still keeping the auditor roll. This we believe, is due to excellent knowledge in his profession and a good knowledge of how business is conducted. A good balance of the two is represented by Salman Raza.
June 16, 2014, Pär worked with Salman but at different companies
I worked with Salman on several projects that released medical products to the International market. As a program manager, I appreciated Salman’s approach of working with the team to identify compliance and regulatory requirements well in advance of needing the verification. Salman is pragmatic, supportive and works with the development team when challenges pop up to get a product released that meets standards and is safe and efficacious ON TIME.
Kit Jordan, PMP
May 20, 2014, Kit worked with Salman in different groups
Technology, Product & Commercial Operations
Salman is a technically- and commercially-aware notified body auditor. I have worked with him through two separate notified bodies as the client manufacturer on two unrelated projects, both involving cutting edge medical devices produced in start-up companies. His involvement in both projects left long-lasting and positive impressions, far beyond the expected scope of the certification audit process itself.
Leader: Healthcare, Life Sciences, Data, AI | AcMedSci FLIER | TEDx Speaker May 20, 2014, Peter was a client of Salman’s
Philips Remote Diagnostic Technologies
It was a privilege to work with Salman. His knowledge of global regulatory requirements is extraordinary. He introduced the concept of Regulatory Compliance Plans to the business. This ensured compliance of new products in ALL target markets from launch, and indeed identified any markets to delay launch due to extreme requirements. Thus helping marketing and the business as a whole to plan ahead. One project we worked on together delivered annual revenues of $25 million after 5 years.
Salman is a great dependable and reliable team player. During new product development, he worked as part of a multifunctional team, including R&D and Marketing. As part of that interaction, he introduced a Usability Engineering Procedure giving visibility of process requirements.
Product development often throws up conflicts. Salman has an innovative approach to conflicts and challenges, whilst maintaining his integrity, honesty, transparency & good humour. The outcome is always a mutually beneficial solution.
Senior Product Manager at Philips Remote Diagnostic Technologies
May 20, 2014, Simon worked with Salman in different groups
Special Projects / NPI
Salman is a very experienced assessor who brought a wealth of experience and insight into our 3rd party external audits. He is a fair and thorough auditor. His ability to look at our QMS from an overview business direction perspective, also made him invaluable as a partner and sounding board for our ideas for the planned general direction of our QMS business processes.
Business Area Quality Manager / Special Projects / NPI
May 20, 2014, Alan was a client of Salman’s
I had the pleasure of working with Salman at CareFusion where he was managing all regulatory affairs regarding the internationally sold infusion pumps the site in the UK were developing. He was a team player always trying to find pragmatic and practical ways to move forward with regards to the product approvals whilst maintaining complete compliance with the various standards and regulations around the globe.
Project Manager at Team Consulting
May 19, 2014, Martin worked with Salman in different groups
Life Sciences Senior Consultant & Expert
Salman is one of the rare auditors having a thorough approach of a company’s management performance, combined to a deep knowledge of relevant standards and regulations. A fast thinking professional, doted with valuable analytical skills and pertinent advices.
Hopefully we will have the opportunity to see each other again in the field.
Life Sciences Senior Consultant & Expert, Quality & Operational Excellence Director, Business Angel & Private Investor
November 19, 2010, Vangelis worked with Salman but at different companies