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To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.

Medapproval works with device manufacturers to develop Technical Documentation including General Safety Performance Requirements (GSPR’s), Biological Panels per ISO 10993-1:2018, ISO 15499, ISO 15223, EN 62366 Usability, ISO 14971:2019, ISO 20416, and ISO 24971 etc. We also advise on Notified Body and Authorized Representative selection.

Medapproval‘s staff has in-depth knowledge in an array of standards including but not limited to:

• ISO11607 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO11135 - Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO11137 - Sterilization of health care products -- Radiation
• ISO14971 - Risk Management
• ISO10993 - Biological evaluation of medical devices

We liaise with Subject Matter Experts to ensure we remain state of the art. In addition to these top tier standards we also have detailed working knowledge of product application standards in the Urological, Anesthesiology, Gastroenterology, Hematology and Infection Control.

Medapproval is one of the few organizations to have directly worked under a US FDA Consent Decree, our experts have developed Gap Analyses, directed teams to prioritize remediation efforts, negotiated with the FDA and US Department of Justice to have the Consent Decree vacated.

Under two subsequent FDA inspections the firm received No Action Indicated (NAI).

We believe our approach is systematic, methodical and result centric. Our Gap Assessments allow critical risks to be identified so as management can apply resources. This prioritization allows a tiered approach where multi-disciplinary teams can implement effective corrections and prevent recidivism, allowing the firm to demonstrate to FDA and Notified Bodies a clear commitment to compliance.

Our team has implemented ISO 13485:2016 conforming programs in Asian and the United States. Our programs are developed to allow compliance with 21 CFR820, 801, and 803. In addition, our systems include the required elements of 2017/745 the EU Medical Device Regulations.

Our work has been demonstrated as effective across a variety of medical devices.

Our team has also developed a critical approach to responses to FDA 483 items, which prevent the issuance of FDA Warning Letters, and in instances where we were engaged too late our Warning Letter responses prevent additional regulatory action.

This multi-disciplinary approach leads to significant reductions in regulatory findings against both the Quality System Regulations, ISO 13485, and 2017/745

Our philosophy is simple, do it right first time and save a lot of effort. With this as our mission statement we also offer US Agent services. We believe that early selection of the right consulting partner fosters teamwork between consultant and firm. Our history has shown us when Medapproval is involved early in the process the firm saves time, talent and treasure.

Medapproval has worked to vacate US Department of Justice (DOJ) Consent Decree where the firm required a systematic change to the quality management system. We organized the remediation team, developed the GAP Analysis strategy to identify and assign resources based on defined risks. We worked with suppliers to conduct revalidations of processes and devices. We managed subsequent FDA inspections, which resulted in No Action Indicated (NAI) and liaised with legal to negotiate with the FDA and DOJ to vacate the Consent Decree.

We continued to work to cement the compliance culture within the organization, which continues to receive NAI inspections.

Medapproval also works early in the compliance process to prevent additional regulatory action with pre FDA audits, compliance tools including GAP analysis to develop comprehensive responses to FDA 483’s, Warning Letters and ISO/EU Findings. Our team has developed a proven process of clearly identifying the regulatory issues and developing tactical responses to satisfy the regulators, while maintaining the business acumen.

Our firm has experience with:

• Pre FDA visits to prepare for the FDA inspection
• Gap Analysis and Assessment
• Hosting FDA on site audits Non-Conformity Responses
• 483 & Warning Letter Responses Services
• Consent Decree’s

As an FDA medical device consulting firm, we have successfully prepared and submitted FDA 510(k) submissions for medical device from around the world seeking to sell in the United States.

To ensure a successful 510(k) submission, we take a two-step approach to obtaining 510(k) clearance from the FDA. Over the years we have found that this approach is cost-effective for our clients, and it dramatically reduces the probability of a failed or abandoned FDA 510(k) submission.

We work with clients early in the design control process to identify the project pathway and define regulatory requirements. This early involvement reduces time to market, producing a competitive advantage with cost avoidance and regulatory compliance.

US FDA Unique Device Identifier (UDI) and Global Unique Device Identifier Database Requirements (GUDID) The U.S. FDA currently requires medical device labelers to:

• Include Unique Device Identifiers (UDI) on their device labels
• Submit device information to the Global Unique Device Identification Database (GUDID)
• Designate a Regulatory Contact for UDI purposes

At Medapproval LLC we make UDI compliance easy and cost effective. We will explain the process, the requirements and find the best way to add your devices.

Our program allows you to determine the exact level of support you need, with flexible cost structures.

We will handle all device classifications, uploading and assigning UDI’s specific to your product. We will also review your labeling, developing a GAP analysis against the full range of US FDA requirements as well as EN ISO 15223:2016, EN 980:2008 and EN 1041:2008+A1:2013.

Contact us today for a quote.