MEDICAL DEVICES

Medical devices continue to play a vital role in the advancement of modern medicine – from neurostimulators, implantable defibrillators and joint replacements to crutches, wearables, medical software and in vitro diagnostics (IVD). Working with Market Now means working with a consultancy that was founded on the premise that better devices hold the promise of a better future for patients.

Medical devices include a wide range of products including pacemakers, artificial heart valves, hip implants, syringes, medical laboratory diagnostic instruments, and contraceptive devices. From medical device classification to establishment registration, we provide all the services necessary to enter the United States and Canadian marketplaces as well as global market with your medical device.

We bring together innovative approached, world-class science, regulatory know-how and a dedicated team to deliver solutions that make a positive impact on public health and quality of life for patients.

Our mission is to provide guidance and value at every step of the device product development process, from concept to clinical trials to commercialization. Regardless of the current stage of your product development, the Market Now team brings the scientific knowledge, regulatory know-how and industry experience necessary to step in and provide hands-on assistance to your team.

Every Step of the Way: Medical Device Specific Path Way to Regulatory Approval

Step One

Our experts will collaborate with your team to assess your product development plan, define all applicable scientific and regulatory requirements, and craft a customized product development and testing strategy that minimizes cost and time to clinical trials, regulatory approval, and commercialization.

Step Two

Market Now will work with your team to identify the appropriate pathway of approval. Once a plan of action has been established, Market Now will be with you every step of the way to manage preliminary documentation and testing, provide hands-on leadership at meetings with the regulators and support your regulatory submission with advice to ensure the best possible submission. Our goal is to craft a document that meets the regulators expectations, leading to an efficient and timely review process.

Step Three

In addition to our expertise in nonclinical testing, clinical trial design and regulatory submission support services, Market Now employs a team of experts in all aspects of testing, manufacturing, storage, and distribution, so you can rest assured that all aspects of your operation are fully compliant with regulators requirements.

Step Four

Our team is well positioned to assist your organization in preparing and submitting your application. During the submission preparation process, we provide hands-on support and guidance. Our team can help translate raw nonclinical and clinical data into a compelling story that will resonate with regulatory reviewers, and lead to the best possible outcomes for your medical device application.

Step Five

Once your device application has been approved and your product is ready to go to market, the Market Now team is able to provide assistance in overseeing manufacturing and quality control, drafting requested periodic updates for the regulators (if required) and assisting your team through additional development and commercialization processes.

Medical Device (FDA) Services

– Regulatory strategic planning and product classification
– Provide expert regulatory CMC compliance advice throughout development
– Determine which similar (predicate) devices already have FDA 510(k) clearance and whether they are suitable for use in your 510(k) submission
– Review testing requirements, applicable FDA guidance documents and required standards
– Provide a detailed product-specific list of documents needed for review by our 510(k) consulting team
– Provide a detailed list of documents, reports, diagrams or clinical data needed before 510(k) preparation can begin
– Prepare a technical comparison of your medical device to other predicate devices with FDA 510(k) clearance
– Medical Device Reporting
– Label review for compliance with 21 CFR part 801

Medical Device (Health Canada) Services

– Regulatory strategic planning and product classification
– Organize and manage meeting(s) with the Therapeutic Products Directorate (TPD)
– Prepare and file CTA’s (Clinical Trial Applications)
– Prepare and file Class II, III and IV applications
– Provide applications support during TPD review
– Perform Quality System audits
– Provide label and advertising review
– Resolve regulatory compliance issues

Inquire about our International Market Access for Medical Device (Australia, EU, South America, Africa, etc.)

Clinical Trial Management

Our clinical trial process from start to finish:

We provide you with a simple process to get your clinical trial started. Market Now will help you design, manage, and execute your clinical trial to the highest level of regulatory and scientific quality.

Develop a Strategy –

Our team will work with you to identify the best possible approach to capture your most significant clinical outcomes through tactfully selected clinical analyses.

Establish Budget and Timelines –

Clinical trials can be costly and time-consuming but our team will work to ensure you stay within your clinical research budget and remain constantly aware of transparent timelines throughout the whole process.

Design Protocol –

A well-designed protocol is critical to achieving your clinical research goals on time and on budget. Let us help you identify the best trial design, trial population and outcomes before designing the best possible protocol for your needs.

Obtain Approvals –

We will manage regulatory submissions to gain Health Canada and REB / IRB approval for your trial.

Recruit Subjects –

Recruitment is one of the most challenging aspects of a trial, let us take charge of finding quality research subjects to complete your trial safely and on time.

Conduct Study –

Our clinical site in downtown Toronto will work to conduct your study with the highest regard for participant safety, data quality and ICH-GCP compliance.

Analyze Results –

Strategic analysis of study results by an experienced team of biostatisticians to capture significant clinical endpoints.

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