Medical Device Consulting
Various medical devices are included under the regulatory definition of a medical device.
Most medical devices are considered high-risk and classified accordingly.
It takes an average of 2-7 years to bring a medical device to the Eu. / US markets.
The journey of a Medical device, from the design phase until you have a safe and effective device with marketing approval, is long. It requires patience, sufficient budget, multidisciplinary skills, in-house professionalism and/or consulting.
There are many challenges throughout the way, from your medical device prototype, development, clinical trials to the commercial phase. Most of the companies hire experienced consultants that have led medical device companies to international success.
Medical device design and development consultancy
A successful medical device design and development process is a unique combination of innovation, quality, and regulatory compliance. Indeed the technology is a significant factor, but as part of my medical device design and development consultancy, I tend to integrate the quality by design principles and other regulatory considerations.
At the end of the day, the device will need marketing approval from the FDA and the CE marking, and we need to set those stepping stones in the design phase.
Suppose you are looking for an experienced consultant for medical device design and development; you should ask yourself:
- Does your consultant have a track record of hundreds of medical projects or development?
- Does your consultant has vast experience in the Bio-Med industry?
- Does your consultant have engineering, technological and regulatory combined capabilities?
- Does your consultant’s track record include quality-related positions?
- Does your consultant experienced with medical software integration
All my medical device consulting projects involved innovative technology, creativity, and simplicity and were fully compliant with the Eu. MDR, MDSAP, ISO 13485, and the US FDA 21 CFR 820.30 regulations.
Medical device strategy consultancy
The medical device global market is heterogeneous, innovative, dynamic, and fascinating. This sector has high growth rates and endless potential in the global economy.
The medical device market offers different solutions and services for patients, physicians, and users.
The medical device industry is competitive, and you need to set the right approach to convert the potential into a success story.
It would be best to define a clear strategy to find the best niche for your medical device.
I have consulted many skilled engineers from various areas, such as mechanics, electronics, nano-technology, automation, computer, data science, and even physicians who bring their brilliant ideas to our Bio-Med industry.
Strategic consulting usually includes milestones such as:
- Market analysis
- Clinical strategy
- Regulatory strategy
- Insurance coverage policies
I always advise my clients to find equivalent medical devices registration codes and classification and think creatively to find the best way to a larger market share with less regulatory effort.
Medical device regulatory consultancy
The regulatory requirements for medical devices are not as stringent as those for pharmaceuticals but still very strict compared to other industries.
As part of my medical device consulting, I’m working with my clients on the safety and effectiveness aspects of the technical file before submission.
Besides all the quality management system requirements, the medical device pre-submission consulting includes various studies reports and documents such as:
- Risk assessment
- Laboratory testing results
- Biocompatible material certification
- Software testing
- Pre-clinical and clinical trials reports
- Clinical evaluation
- Verification & Validation
- Information security
- Patient information privacy
Usually, there is no second chance in front of the global regulatory bodies, and you have to do it right the first time.
I recommend you use consultants with a holistic approach, multi-areas professionalism, and experience to assist you all the way until you sell your medical device in the US and Europe.
Medical device quality consultancy
To have a safe and effective medical device in the markets, you need to be aligned with the quality regulatory requirements and good practices.
In parallel to the medical device design phase, you need experienced quality management consulting to establish your own company’s quality management system.
First of all, you need to define, together with your Medical device quality consultant, what kind of quality management system will support your business goals best.
This decision can be based on different considerations such as:
- Medical device type
- Medical device classification
- Risk level
- Target markets
- Regulatory requirements
- Territory/local regulations
Many global QMS regulations include the ISO 13485, MDSAP, 21 CFR part 820, and others.
Basically, all quality management system relays on the same principles, such as risk-based approach, control, and continuous improvement.
As part of the medical device QMS consulting phase, I will analyze the quality gaps, establish your own SOP template and write all your policies and procedures tailored to your company needs based on product characteristics, the development phase, and business goals.
After documents approval, I will train all relevant employees, and we will begin to assimilate the procedures into the day-to-day activities.
As part of the quality consulting process, I always tell my clients that all activities in the company have to be well defined and documented accordingly.
At the end of the medical device quality consulting phase, I will conduct a mock audit towards the third-party external audit to maximize the chances of having the quality certification as soon as possible.
To achieve the milestones effectively, you need medical device consulting services at several checkpoints along the process.
Hiring the right medical device consultant will surely save you precious time and money along the way.
I have 20 years of intensive experience in medical device consulting and supporting novel technologies development and start-ups in their fascinating journey until regulatory marketing approval.