Medical Device certification requirements can be a bottleneck in getting new or improved products to market. Regulatory missteps in launching new medical devices can cost companies thousands or even millions of dollars in lost sales.
Companies that can successfully navigate the regulatory requirements for medical devices and launch a new standards-compliant product have a real market advantage.
Medical Device Definition
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article, which medical professionals use to diagnose, prevent or treat disease or other conditions. A medical device does not achieve its purposes through chemical action within or on the body, which would make it a drug.
Medical Device Services
If you want to market your medical device to a global market, you must establish a compliant quality management system.
We are experts in guiding clients through the complexities of medical device regulations. We do not take a quick fix approach. We do more than help clients obtain their desired certification. Our team is committed to adding real value to each client’s bottom line.
We are also committed to clients for the long-haul. Companies must nurture their quality management system to maintain the system’s effectiveness. We help clients with ongoing support services. With this ongoing support, clients minimize their risk of triggering a costly re-audit.
Our consultants have guided countless companies to successful certification in the following standards and regulations.
FDA 21 CFR Part 820 governs the methods organizations use to design, manufacture, package, label, store, install and serve all finished devices for human use.
Under this regulation manufacturers, specification developers, contract manufacturers, re-labelers and re-processors must develop a quality regulations system (QSR). This regulation does not define the specifics of the QSRs. It details the requirements covered entities must follow in establishing their QSRs.
FDA QSR Consulting Services
Our consulting team has worked with global Fortune 500 companies and small start-up manufacturers. We can assist clients in range of QSR services from helping clients establish design controls through conducting audits. We will scale our consulting efforts to match the needs of each client’s products and culture.
Our consulting services can include:
- Design control procedures, implementation and audits
- Design development plan
- DMR (device master record)
- Risk management program development, and analysis
- Medical Device product design history file compliance
- Biocompatibility and sterilization assessment
- Medical device standards assessment
- Process validation (IQ/OQ/PQ)
- Change control
ISO 13485:2003 (CMDCAS) and ISO 13485:2016
The ISO 13485 standard covers the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The ISO has currently revising the 13845 standard. The working title of the next revision is now ISO 13485:2016.
ISO 13485 Services
Our consulting team can make sure that the QMS for your medical device initiatives comply with the current standards. We can also help you understand the expected standard revisions and make sure your system can easily adapt to the new version. We work with clients in the Europe, the US and Canada and can consult on CMDCAS.
With our services, we can help you:
- Establish your ISO 13485-compliant quality management system criteria
- Conduct a GAP Analysis
- Identify deficiencies and recommend corrective actions
- Establish your business processes
- Define your training requirements
- Implement your quality management system
- Develop your record reporting procedures
- Conduct pre-audit assessment
- Manage the certification process
The European Commission (EC) published the Medical Device Directive in 1993. Entities can only sell medical devices in Europe that carry the EC’s CE Mark. With this mark, manufacturers declare that the device meets the applicable EC standards.
To place a CE mark on a device, the European Community requires that manufacturers comply with one of three special directives: Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD) or the Active Implantable Medical Device Directive (AIMDD).
Without the CE Mark you cannot sell your medical device within the European Community.
CE Mark Services
Our experienced consultants will guide you in obtaining the appropriate CE Mark. We can help you:
- Determine the relevant EU classification for your device
- Prepare your technical file
- Prepare your audit application
- Work through the audit process
- Identify a responsible person (a EU-based CE Mark representative for your company)
Our experts in medical devices can assist your team in all aspects of compliance, regulation and standards.
For a no-obligation proposal, please contact us.
- JJK Consulting Inc. will help your company to tackle the Globalized GMP Challenges for Cosmetics and Cosmetic Ingredients.
- Our team will guide you through the requirement for the domestic or international market.
- The global experience of our group of professionals will evaluate and customize your systems and processes to assure excellence in compliance and certification.
- Many of the QMS/GMP processes are critical to today’s Cosmetics industry standards. Our team has over 50 years of experience in cosmetics and can help you achieve your goals in certification and quality.
Today, few industries face more regulations than pharmaceutical manufacturers. We work with companies that need to meet the top quality standards for drug manufacturing, including cGMP, GLP, GCP and 21FR Part 11.
If you want to sell pharmaceuticals in the US, you must meet the US FDA’s requirements for Current Good Manufacturing Practice (cGMP). By adopting a cGMP, you can prove that you manufactured a specific batch of a regulated product to meet a pre-defined manufacturing standard.
The FDA regularly conducts cGMP inspections of companies that manufacture, produce, store or label drugs sold in the US.
The FDA will inspect facilities for a variety of reasons, including:
- As a part of the agency’s normal routine inspection process
- In response to complaints
- To verify the truthfulness of a submission
Regardless of the reason for the FDA’s inspection, your entire team must be ready. If your staff does not understand and prepare for an FDA inspection, you risk a negative outcome, which can cost you. Our consultants will help you fully understand and get ready for your FDA inspection.
To prepare your facility for a FDA cGMP Inspection, our consultants will
- Review your Standard Operating Procedures (SOP)
- Conduct an audit and provide a GAP analysis
- Identify deficiencies and recommend corrective actions
- Guide you in preparing your staff and site for inspection
- Advise you on how to interact with the FDA inspector
- And more
Good Laboratory Practice (GLP) is a quality system focused on the process and conditions companies use to plan, perform, monitor, record, archive and report non-clinical health and environmental safety studies.
A company adapts a GLP to protect the integrity of its scientific data and to provide the FDA (or EPA) with a clear, auditable record of open-ended research studies.
With our GLP consulting services, our team can:
- Inspect your subcontractors and vendors for GLP compliance
- Analyze your data reports against GLP requirements
- Inspect your facilities and relevant computer systems
- Review your SOPs
- Advise on how to remediate any GLP deficiencies in your systems or SOPs
- Guide you through GLP certification
- And more
Good Clinical Practices (GCP) is an international quality standard for designing, conducting, recording, and reporting trials, which involve human subjects.
Our consultants collaborate with clients to help them develop GCP-compliant processes.
The JJK Consulting group is not a contract research organization (CRO). We only provide GCP consulting services.
With our independence from the clinical trial process, we can objectively evaluate your clinical trials without triggering any potential conflict of interest. Our objectivity means we will always have your best interests as our main interest.
With our GCP consulting services, our team can:
- Tour your facilities
- Review your standard SOPs
- Evaluate your QMS
- Appraise your compliance with your SOPs
- Assess your vendors’ qualifications, management and certification programs
- Review the qualifications and training of the CRO team members
- And more
21 CFR Part 11
Title 21 CFR Part 11 refers to the section of the US FDA regulations related to electronic records and electronic signatures.
If your organization uses a computer system to manage electronic records related to an FDA-regulated product or program, your system must comply with this regulation. Our consulting team thoroughly understands these requirements.
21 CFR Part 11 Services
To ensure that your systems comply with 21 CFR Part 11, our consultants will:
- Analyze the risks of your current electronic records systems
- Review your SOPs
- Asses your computer system against your SOPs and FDA’s compliance requirements
- Identify non-compliant elements
- Prepare a remediation plan
- Assist your team in making changes
- Provide ongoing support to assure your systems remain compliant
No matter if you are developing a new validation or qualification program, require immediate remediation to a compliance issue, or want to have your existing solutions audited, JJK will provide you with the services you need.
For a no-obligation quote, please contact us.
Major food manufacturers, distributors and food retailers are now sourcing suppliers from distant locations. To lessen the risk of a high-profile food safety incident, companies in the food industry are adapting Global Food Safety Initiative (GFSI) standards.
GFSI recognizes a number of Food Safety Management Systems Certification programs, based on the Hazard Analysis Critical Control Point (HACCP) system, including:
- Safety Quality Food (SQF)
- Food Safety Systems Certification (FSSC) 22000 and ISO 2200
- British Retail Consortium (BRC)
If you want to sell food products to major corporations, you must meet international food safety standards. Only suppliers obtaining third-party certification to a GFSI standard can give buyers objective proof of their food-product’s safety.
When your organization achieves certification to a GFSI-accepted standard, you will gain your potential customers’ trust. All large buyers in the food industry demand some type of certification. If you want to remain competitive in this industry, you must obtain and maintain certification.
Our experienced team of food-standards consultants will prepare your company to meet the most recognized food safety and quality standards.
Our team can help you through the entire process of implementing a food safety program to comply with relevant international standards. We work with companies just starting to develop a food safety system and established organizations needing compliance assistance.
Our consultants will
- Assist you determining the best audit scheme for you
- Assess your current food safety process against your target scheme
- Help you develop and implement a safety program meeting your target standard
- Guide you through the certification process
Our food standards consultants have provided auditing and consulting services to the most prestigious companies in the world for decades including Nestle and Coca Cola
Our professionals have successfully guided clients through food-standards certification countless times. As a team, we know what to expect. With our experience, our clients get fully prepared and experience no surprises at audit time.
To receive a no obligation proposal on how we can help your company meet the international food safety standard, please contact us.
A quality management system (QMS) covers a set of business processes focused on achieving quality policy and quality objectives to meet customer requirements.
Good manufacturing practice (GMP) is a system that ensures organizations produce and control products consistently aligned with quality standards. GMP is part of a QMS that covers the manufacturing and testing of pharmaceuticals, active pharmaceutical ingredients, diagnostics, foods, and medical devices.
Regulators develop GMP requirements to minimize the risks involved in pharmaceutical production. Although many countries develop country or region-specific pharmaceutical and medical device quality standards, GMP guidelines follow a few basic principles.
With a GMP, the entity must:
- Clearly define and control its manufacturing process
- Validate critical processes to ensure consistency and compliance with established specifications
- Evaluate and validate any changes, which have an impact on quality
- Write instructions and procedures in clear and unambiguous language
- Train staff to perform operations in line with documented procedures
- Keep manufacturing records and document and investigate deviations from the set standard
- Keep records of distribution to enable tracing and history of a specific batch
- Establish a system to enable any necessary product recalls for specific batch
QMS and GMP Services
- Our team of consultants can help you establish and maintain a standards-compliant GMP system. We can help you:
- Design and implement a QMS appropriate for your organization and target markets
- Prepare for regulatory submissions
- Design and implement an effective validation system for processes and suppliers
- Audit suppliers and/or vendors
- Conduct a pre-certification audit for all processes
- Establish the appropriate record keeping and tracking systems
- And more
Regulators use Quality Management Systems and Good Manufacturing Practices as the foundation for their certification standards. JJK consulting has constructed a team of veterans across every industry and business sector. Our approach will demystify the process and lead to measurable, repeatable results that have bottom line impact.
To discover how we can help you improve your bottom line with a well-structured QMS system, please contact us.
JJK Consulting employs some of the industry’s most experienced professionals having worked extensively with global companies like Chrysler, Nestle, Coca Cola, Estee Lauder and Walmart. They have worked across North America and most are multilingual. Social accountability and sustainability is a global movement and our team is at the forefront. Social responsibility is good for your most important resource, your people and ultimately good for business.