All AlvaMed projects are unique to our clients’ needs. Projects range in size from $1,000 to $200,000. Our services are charged on a: 1. “Time and Materials” basis at hourly rates ranging between $100 and $400 depending upon seniority; or, 2. A “Fixed Fee” monthly fee when we provide internal functions within your organization. These range from: a) $2,000 per month for document control support; to, b) $30,000 per month for ongoing quality assurance, regulatory and clinical affairs support. We are most comfortable breaking larger efforts into more manageable phases. While we can provide estimates going out a year in advance, we most often find it practical to propose and agree on projects with a 3-month duration. We can start work quickly – often in less than 2 weeks – by following this process: 1. Click this link and contact us. 2. We will set a time for an initial business meeting – a “relationship meeting” – to discuss your needs and whether AlvaMed is a good fit for the support you need. Prior to the meeting we usually sign a confidentiality agreement to provide you with the assurance of the protection of your intellectual property. This initial meeting is typically a 30-minute discussion with one of AlvaMed’s principals – Mark Cox, Jon Saltonstall, or Eric Bannon. The objective of the meeting is to verify that forming a business relationship is attractive to both parties. 3. If agreed, AlvaMed will then arrange a “project meeting” to discuss the technical objectives of the project. Typically an hour meeting, you will meet and discuss the project with the actual project team. The objective of this meeting is to determine the objectives and approach for the project. During this meeting, we discuss schedule, budget, and any key milestones. 4. With the output of the “project meeting” AlvaMed creates a formal proposal for the project that, when signed, will serve as our agreement. Most of our projects have a compliance component and in most cases, we are required to be an approved supplier. We have internal processes that are Part 11 compliant, so this process can be completed quickly. Should you be a larger company, we are happy to review and agree to a Master Services Agreement. 5. Once the project is complete a quality representative from AlvaMed will call you to briefly discuss the outcome and quality of our work. We will set a time for an initial business meeting – a “relationship meeting” – to discuss your needs and whether AlvaMed is a good fit for the support you need. Prior to the meeting we usually sign a confidentiality agreement to provide you with the assurance of the protection of your intellectual property. This initial meeting is typically a 30-minute discussion with one of AlvaMed’s principals – Mark Cox, Jon Saltonstall, or Eric Bannon. The objective of the meeting is to verify that forming a business relationship is attractive to both parties.

About Us - Alvamed

Insights

Browse our educational materials to stay informed on industry trends and news.

Resources

Our compilation of external links to provide quick access to crucial content such as regulations, warning letters, alerts, and databases.

Newsletters

AlvaMed’s articles covering topics that impact our industry.

Case Studies

Explore our case studies showcasing how we effectively address various challenges and deliver the results our clients need.

About Us

AlvaMed is a consulting firm to the medical device industry. We offer a comprehensive suite of compliance services to our clients, covering quality assurance, quality system development, regulatory approval and compliance, as well as CRO/clinical management services.

Team

Meet our team of industry experts ready to share their knowledge to help drive your business success.

Careers

Explore open positions available at AlvaMed.

Testimonials

Hear feedback from our clients as they share their outcomes and detail how AlvaMed played a pivotal role in helping them achieve their goals.

Who We Are

Our mission is to consistently deliver expert, custom-tailored solutions that enable our medical device clients to achieve their goals swiftly and efficiently.

Complete Medical Device Consulting Solutions

Regulatory Services

Q-Subs, 510(k)s, De Novos, IDEs, EU MDR Technical Documentation, Clinical Evaluation Reports, and other submissions
Device Establishment registration and listings
Regulatory strategic planning including device classifications, expert opinions, and due diligence requests
FDA Registered Agent representative

Design Assurance Services

CRO and Clinical Affairs Services

US/OUS clinical study protocol development and approval
Clinical site management from initiation to closeout, including TMF maintenance and CRA contracting and management
IRB/EC management and reporting
Cost-effective EDC and database oversight
Establishment and execution of Data Safety Management Board

Quality Management Systems (QMS) Services

QMS design, implementation, and maintenance to meet FDA, EU MDR, and ISO 13485 requirements
Serving as the Management Representative
Available “QMS in a Box” includes compliant, yet lightweight SOPs and forms that can be deployed quickly
Internal and supplier auditing
Multi-site QMS harmonization
QMS/audit finding remediation

Mark Cox founded AlvaMed in 2002 to provide consultation services to medical device companies throughout the product lifecycle. By providing smart, right-sized regulatory pathways and quality management systems, our team applies years of know-how to accelerate business milestones.

AlvaMed’s highly knowledgeable team of experts has helped clients throughout Asia, the Americas and Europe develop and introduce new medical products. Our staff, with backgrounds in science, engineering, technical writing, and clinical affairs, bring specialized expertise to the table, skillfully crafting solutions to propel client milestones forward. The AlvaMed team is passionately dedicated to client success, emphasizing the use of creative solutions and a balanced approach to risk tolerance.

Outsourcing to AlvaMed brings in time-saving expertise while saving overhead costs. We tailor our approach to the needs of your company – addressing gaps in your team or systems.

Contact Mark Cox directly to talk about your project.

Regulatory, Quality, and Clinical Support Tailored to Your Requirements

What we offer

We can seamlessly integrate into your company’s regulatory, quality, and clinical affairs functions.

Our team has 75+ years of combined expertise in QMS without the large overhead and high cost.

We eliminate the need to hire staff during periods of lesser workloads, provide flexibility and eliminate investments in extra infrastructure.

We have a comprehensive quality, regulatory and clinical team who will be there for you in the future, as opposed to engaging different individual experts each time.

We offer a range of services tailored to meet your needs, spanning from reviews and expertise to managing both small and large projects, providing continuous support on either a short- or long-term basis.

How we work

AlvaMed is an industry leader in medical device consulting and is comprised of technically savvy clinical, quality and regulatory professionals comprising a broad range of complementary skills. Our team’s flexibility enables us to swiftly adjust our support levels to accommodate your evolving needs. Committed to fostering long-term relationships, we prioritize client input and tailor our services and solutions accordingly.

We offer a large library of customizable regulatory submission, quality manual, SOP and other templates to support clients. Moreover, we have helped develop entire quality management systems from scratch for multiple companies and offer vast clinical affairs and regulatory support.

A FIRST PROJECT:

All AlvaMed projects are unique to our clients’ needs.

Projects range in size from $1,000 to $200,000. Our services are charged on a:

1. “Time and Materials” basis at hourly rates ranging between $100 and $400 depending upon seniority; or,
2. A “Fixed Fee” monthly fee when we provide internal functions within your organization. These range from:
a) $2,000 per month for document control support; to,
b) $30,000 per month for ongoing quality assurance, regulatory and clinical affairs support.

We are most comfortable breaking larger efforts into more manageable phases. While we can provide estimates going out a year in advance, we most often find it practical to propose and agree on projects with a 3-month duration.

We can start work quickly – often in less than 2 weeks – by following this process:

1. Click this link and contact us.
2. We will set a time for an initial business meeting – a “relationship meeting” – to discuss your needs and whether AlvaMed is a good fit for the support you need. Prior to the meeting we usually sign a confidentiality agreement to provide you with the assurance of the protection of your intellectual property. This initial meeting is typically a 30-minute discussion with one of AlvaMed’s principals – Mark Cox, Jon Saltonstall, or Eric Bannon. The objective of the meeting is to verify that forming a business relationship is attractive to both parties.
3. If agreed, AlvaMed will then arrange a “project meeting” to discuss the technical objectives of the project. Typically an hour meeting, you will meet and discuss the project with the actual project team. The objective of this meeting is to determine the objectives and approach for the project. During this meeting, we discuss schedule, budget, and any key milestones.
4. With the output of the “project meeting” AlvaMed creates a formal proposal for the project that, when signed, will serve as our agreement. Most of our projects have a compliance component and in most cases, we are required to be an approved supplier. We have internal processes that are Part 11 compliant, so this process can be completed quickly. Should you be a larger company, we are happy to review and agree to a Master Services Agreement.
5. Once the project is complete a quality representative from AlvaMed will call you to briefly discuss the outcome and quality of our work.

We will set a time for an initial business meeting – a “relationship meeting” – to discuss your needs and whether AlvaMed is a good fit for the support you need. Prior to the meeting we usually sign a confidentiality agreement to provide you with the assurance of the protection of your intellectual property. This initial meeting is typically a 30-minute discussion with one of AlvaMed’s principals – Mark Cox, Jon Saltonstall, or Eric Bannon. The objective of the meeting is to verify that forming a business relationship is attractive to both parties.

REPEAT BUSINESS

More than 90% of our business is repeat business. After developing a business relationship, we can quickly respond to additional needs or changes as they arise.

AlvaMed meets with prospective clients to understand their potential needs and requirements. After meeting and discussing your project, AlvaMed develops a proposal based on your specific needs. Our services range from opinions and reviews to short and long-term projects. Proposals provide the objective of our project, the scope of our work and an estimated timeframe for completion. AlvaMed remains in direct contact throughout the entire project and gives updates as we progress on the work.

Please check out our Case Studies to see how AlvaMed has approached and tackled a variety of projects for numerous clients.

Our Values

Our commitment to our customers is intrinsic to AlvaMed. Using a client-centric approach, we actively engage with our clients to gain insights into their specific business goals, regulatory context, and operational intricacies. Every day, we are dedicated to exemplifying the core values that we consider fundamental to our business and lives.

We continuously create, optimize, and are agile enough to provide the right size, custom tailored solutions to the evolving needs of our clients.

We relentlessly seek ways to provide straightforward strategies and tactics to our clients knowing our only purpose is their success. We know that unity and teamwork lead to greater achievements for all.

We are dedicated to interpreting regulations thoroughly and offering a variety of intelligent solutions while balancing risk. Our innovative solutions deliver long lasting results and have a positive impact.

We are always honest and transparent. We focus on doing the right thing with a moral compass that does not waver. Our commitment to our colleagues and clients is to always conduct ourselves with the utmost integrity.

We are dedicated to surpassing the customary level of service and consistently deliver on our promises and commitments. Our results are exceptional, and in turn, we build trust, loyalty and a positive reputation.

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